<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981407</url>
  </required_header>
  <id_info>
    <org_study_id>Pro20160000722</org_study_id>
    <secondary_id>1U01HL133817-01</secondary_id>
    <nct_id>NCT02981407</nct_id>
  </id_info>
  <brief_title>Myocardial Ischemia and Transfusion</brief_title>
  <acronym>MINT</acronym>
  <official_title>Myocardial Ischemia and Transfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two red blood cell transfusion strategies (liberal&#xD;
      and restrictive) for patients who have had an acute myocardial infarction and are anemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion.&#xD;
      However, for those who have suffered a heart attack, there is a lack of high quality evidence&#xD;
      to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.&#xD;
&#xD;
      Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10&#xD;
      g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.&#xD;
&#xD;
      Patients randomized to the liberal transfusion strategy will receive a red blood cell&#xD;
      transfusion anytime there is a blood count of less than 10 g/dL.&#xD;
&#xD;
      Patients randomized to the restrictive transfusion strategy are permitted to receive a blood&#xD;
      transfusion if the blood count is below 8 g/dL and the physician believes it is in the&#xD;
      patient's best interest. A transfusion will be strongly recommended if the blood count drops&#xD;
      to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described&#xD;
      as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered&#xD;
      regardless of the blood count.&#xD;
&#xD;
      The transfusions strategies will be maintained until hospital discharge for a maximum of 30&#xD;
      days.&#xD;
&#xD;
      Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be&#xD;
      confirmed at 180 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Actual">May 31, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite outcome of all-cause mortality or nonfatal myocardial reinfarction</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial reinfarction</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of all-cause mortality, nonfatal myocardial reinfarction, ischemia driven unscheduled coronary revascularization, or readmission to the hospital for ischemic cardiac diagnosis</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Composite of all-cause mortality,nonfatal myocardial reinfarction, or unstable angina</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Ischemia driven unscheduled coronary revascularization</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Unscheduled readmission to hospital for ischemic cardiac diagnosis</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Congestive heart failure</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Unscheduled readmission to hospital for any reason</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Stroke</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pulmonary embolism or deep venous thrombosis</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Bleed</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pneumonia</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Blood stream infection</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Urinary tract infection</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Length of hospital stay post randomization</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of days post randomization in intensive care unit</measure>
    <time_frame>Within 30 days of randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Patient reported quality of life</measure>
    <time_frame>Within 30 days of randomization</time_frame>
    <description>EuroQol questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Within 6 months of randomization</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3506</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Liberal Transfusion Strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restrictive Transfusion Strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Red Blood Cell Transfusion</intervention_name>
    <description>Transfusion of packed red blood cell units</description>
    <arm_group_label>Liberal Transfusion Strategy</arm_group_label>
    <arm_group_label>Restrictive Transfusion Strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Either ST segment elevation myocardial infarction or Non ST segment elevation&#xD;
             myocardial infarction consistent with the 3rd Universal Definition of Myocardial&#xD;
             Infarction criteria that occurs on admission or during the index hospitalization&#xD;
&#xD;
          -  Hemoglobin concentration less than 10 g/dL at the time of random allocation&#xD;
&#xD;
          -  Patient physician believes that both of the transfusion strategies are consistent with&#xD;
             good medical care for the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled acute bleeding at the time of randomization defined as the need for&#xD;
             uncrossed or non-type specific blood&#xD;
&#xD;
          -  Decline blood transfusion&#xD;
&#xD;
          -  Scheduled for cardiac surgery during the current admission&#xD;
&#xD;
          -  Receiving only palliative treatment&#xD;
&#xD;
          -  Known that follow-up will not be possible at 30 days&#xD;
&#xD;
          -  Previously participated in MINT&#xD;
&#xD;
          -  Currently enrolled in a competing study that interferes with the intervention or&#xD;
             follow-up of MINT or enrolled in a competing study that has not been approved by the&#xD;
             local Institutional Review Board&#xD;
&#xD;
          -  Patient physician does not believe the patient is an appropriate candidate for the&#xD;
             trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey L Carson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Robert Wood Johnson Medical School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Mori Brooks, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Arkansas Veterans Healthcare System</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas Medical Sciences (UAMS) Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VAGLAHS</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danbury Hospital</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Medical Center</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMITA Health</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <zip>60521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Mid America Heart</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>01930</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Mercy Health System</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Health</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center Fairview</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute (Foundation)</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407-1130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital at Gulfport</name>
      <address>
        <city>Gulfport</city>
        <state>Mississippi</state>
        <zip>39502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Copper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensacjk University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jersey Shore University Medical</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>08759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Wood Johnson University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical College</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southside Hospital</name>
      <address>
        <city>Bay Shore</city>
        <state>New York</state>
        <zip>11706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYP Brooklyn Methodist</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian/Queens</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westchester Medical Center</name>
      <address>
        <city>Hawthorne</city>
        <state>New York</state>
        <zip>10532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Westchester Hospital</name>
      <address>
        <city>Mount Kisco</city>
        <state>New York</state>
        <zip>10549</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center, Bellevue Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hilll Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester General Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Staten Island Hopsital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook Medicine</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8167</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7097</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham Va</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WakeMed Health and Hospital</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aultman Hospital</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancaster General Hospital</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PENN Presbyterian Medical Cente</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Memphis VAMC</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor St Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin - Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Repatriation General Hospital</name>
      <address>
        <city>Concord</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gosford Hospital</name>
      <address>
        <city>Gosford</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Ensino e Pesquisa do Hospital da Bahia</name>
      <address>
        <city>Pituba</city>
        <state>Salvador</state>
        <zip>41810</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de Rio Preto</name>
      <address>
        <city>São José do Rio Preto</city>
        <state>São Paulo</state>
        <zip>15080-310</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Felício Rocho</name>
      <address>
        <city>Belo Horizonte</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Orizonti</name>
      <address>
        <city>Belo Horizonte</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil</name>
      <address>
        <city>Brasília</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vera Cruz</name>
      <address>
        <city>Campinas</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Marília</name>
      <address>
        <city>Cascata</city>
        <zip>17515-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedade Hospitalar Angelina Caron</name>
      <address>
        <city>Centro</city>
        <zip>83430-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Cardiologia do RS</name>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Maternidade e Pronto Socorro Santa Lúcia</name>
      <address>
        <city>Poços De Caldas</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Agamenon Magalhães</name>
      <address>
        <city>Recife</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE</name>
      <address>
        <city>Recife</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Cárdio Pulmonar</name>
      <address>
        <city>Salvador</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Professor Edgard Santos</name>
      <address>
        <city>Salvador</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de Rio Preto</name>
      <address>
        <city>São José Do Rio Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas da UFTM</name>
      <address>
        <city>Uberaba</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas da UFU</name>
      <address>
        <city>Uberlândia</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grey Nuns Community Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Columbian Hospital</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surrey Memorial Hospital</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Boniface General Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QE II Health Sciences Center</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton St. Joseph's Health</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Health Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital - LHSC</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria Hospital - LHSC</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria Heart Institute</name>
      <address>
        <city>Victoria</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles Lemoyne</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hotel-Dieu de Levis</name>
      <address>
        <city>Levis</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hosp. Universitaire de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quebec Heart and Lung Institute</name>
      <address>
        <city>Québec City</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Trois-Rivièrs</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regina General Hospital</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Tours -Hôpital Trousseau</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Chartres - Chartres</name>
      <address>
        <city>Chartres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU le Bocage - Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Tronche Hôpital Michallon</name>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Arnaud de Villeneuve - Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pasteur</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Universitaire Carémeau (CHU Carémeau)</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges-Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital BICHAT- APHP</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Lariboisière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Haut Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers - Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles Nicolle- Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gisborne Hospital</name>
      <address>
        <city>Gisborne</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nelson Hospital</name>
      <address>
        <city>Nelson</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taranaki Hospital</name>
      <address>
        <city>New Plymouth</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whangarei Hospital</name>
      <address>
        <city>Whangarei</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>France</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.</citation>
    <PMID>23708168</PMID>
  </reference>
  <reference>
    <citation>Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.</citation>
    <PMID>27732721</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Jeffrey L Carson, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Red Blood Cell Transfusion</keyword>
  <keyword>Anemia</keyword>
  <keyword>Heart Disease</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02981407/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981407
org study id: Pro20160000722
secondary id: 1U01HL133817-01
nct id: NCT02981407
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to compare two red blood cell transfusion strategies (liberal
      and restrictive) for patients who have had an acute myocardial infarction and are anemic.
In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion.
      However, for those who have suffered a heart attack, there is a lack of high quality evidence
      to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.

      Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10
      g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.

      Patients randomized to the liberal transfusion strategy will receive a red blood cell
      transfusion anytime there is a blood count of less than 10 g/dL.

      Patients randomized to the restrictive transfusion strategy are permitted to receive a blood
      transfusion if the blood count is below 8 g/dL and the physician believes it is in the
      patient's best interest. A transfusion will be strongly recommended if the blood count drops
      to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described
      as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered
      regardless of the blood count.

      The transfusions strategies will be maintained until hospital discharge for a maximum of 30
      days.

      Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be
      confirmed at 180 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Composite outcome of all-cause mortality or nonfatal myocardial reinfarction
time frame: Within 30 days of randomization
measure: All-cause mortality
time frame: Within 30 days of randomization
measure: Myocardial reinfarction
time frame: Within 30 days of randomization
measure: Composite of all-cause mortality, nonfatal myocardial reinfarction, ischemia driven unscheduled coronary revascularization, or readmission to the hospital for ischemic cardiac diagnosis
time frame: Within 30 days of randomization
measure: Composite of all-cause mortality,nonfatal myocardial reinfarction, or unstable angina
time frame: Within 30 days of randomization
measure: Ischemia driven unscheduled coronary revascularization
time frame: Within 30 days of randomization
measure: Unscheduled readmission to hospital for ischemic cardiac diagnosis
time frame: Within 30 days of randomization
measure: Congestive heart failure
time frame: Within 30 days of randomization
measure: Unscheduled readmission to hospital for any reason
time frame: Within 30 days of randomization
measure: Stroke
time frame: Within 30 days of randomization
measure: Pulmonary embolism or deep venous thrombosis
time frame: Within 30 days of randomization
measure: Bleed
time frame: Within 30 days of randomization
measure: Pneumonia
time frame: Within 30 days of randomization
measure: Blood stream infection
time frame: Within 30 days of randomization
measure: Urinary tract infection
time frame: Within 30 days of randomization
measure: Length of hospital stay post randomization
time frame: Within 30 days of randomization
measure: Number of days post randomization in intensive care unit
time frame: Within 30 days of randomization
measure: Patient reported quality of life
time frame: Within 30 days of randomization
description: EuroQol questionnaire
measure: All-cause mortality
time frame: Within 6 months of randomization
arm group label: Liberal Transfusion Strategy
arm group type: Active Comparator
description: Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days.
arm group label: Restrictive Transfusion Strategy
arm group type: Active Comparator
description: Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count.
intervention type: Biological
intervention name: Red Blood Cell Transfusion
description: Transfusion of packed red blood cell units
arm group label: Liberal Transfusion Strategy
arm group label: Restrictive Transfusion Strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey L Carson, MD
role: Principal Investigator
affiliation: Rutgers Robert Wood Johnson Medical School
last name: Maria Mori Brooks, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
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country: Australia
country: Brazil
country: Canada
country: France
country: New Zealand
country: United States
citation: Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.
PMID: 23708168
citation: Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
PMID: 27732721
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Jeffrey L Carson, MD
investigator title: Principal Investigator
mesh term: Myocardial Infarction
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Infarction
mesh term: Ischemia
sharing ipd: Yes
ipd description: Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.
provided document: 