<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/NCT02972593</url>
  </required_header>
  <id_info>
    <org_study_id>1402557771</org_study_id>
    <nct_id>NCT02972593</nct_id>
  </id_info>
  <brief_title>ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion</brief_title>
  <acronym>ORACL</acronym>
  <official_title>ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atlanta Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if there is a difference in outcomes between&#xD;
      liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and&#xD;
      conservative transfusion (transfusing when hemoglobin drops below a set lower value number).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transfusion of Orthopaedic trauma patients is routinely done in asymptomatic individuals as&#xD;
      there is no accepted national standard or recommendations from the American Academy of&#xD;
      Orthopaedic Surgeons or the Orthopaedic Trauma Association for what level of anemia is&#xD;
      appropriate in an asymptomatic patient. Individual practitioners typically make this decision&#xD;
      based on anecdotal experiences and expert opinion. No prospective study has been performed to&#xD;
      date to answer this question in this patient population.&#xD;
&#xD;
      The null hypothesis of this proposed pilot study is that no difference will be seen with a&#xD;
      liberal transfusion strategy to keep a patient's hemoglobin above 7 g/dL versus a&#xD;
      conservative strategy to keep the patient's hemoglobin above 5.5 g/dL in patients&#xD;
      asymptomatic at rest. The primary outcome of this pilot study will be infection; defined as&#xD;
      postoperative wound infection (superficial or deep) or other perioperative infection but not&#xD;
      surgical site (urinary tract infection or pneumonia). Deep infection is defined as the need&#xD;
      for intravenous antibiotics or a return to surgery for debridement. Superficial infection is&#xD;
      defined as the use of oral antibiotics only successfully treat a surgical site infection.&#xD;
      Secondary outcomes will include pulmonary embolism, deep venous thrombosis, acute renal&#xD;
      failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve&#xD;
      palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death, and the&#xD;
      musculoskeletal functional assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">June 24, 2022</completion_date>
  <primary_completion_date type="Actual">June 24, 2022</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection</measure>
    <time_frame>one year</time_frame>
    <description>Deep infection is defined as the need for intravenous antibiotics and/or a return to surgery for debridement. Superficial infection is defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Combined Secondary Outcomes</measure>
    <time_frame>one year</time_frame>
    <description>Combined (any) Secondary Outcomes: pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculoskeletal Function Assessment</measure>
    <time_frame>one year</time_frame>
    <description>The Musculoskeletal Function Assessment (MFA) evaluates the health status of patients with musculoskeletal disorders of the extremities, including patients with fractures and soft tissue injuries, repetitive motion disorders, osteoarthritis or rheumatoid arthritis. It describes patient functioning, assesses outcomes of surgical interventions and clinical trials, and monitors patients' functional status over time. The MFA is scored from 0 to 100 with 0 representing no dysfunction. Higher MFA scores/values represent a higher levels of dysfunction or worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Liberal</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood and blood products for transfusion. Transfusion will be done to keep Hgb &gt;7 g/dL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Blood and blood products for transfusion. Transfusion will be done to keep Hgb &gt; 5.5 g/dL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood and blood products for transfusion</intervention_name>
    <description>Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb &gt;7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.</description>
    <arm_group_label>Conservative</arm_group_label>
    <arm_group_label>Liberal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Trauma patients admitted to participating hospital with any Orthopaedic injury who&#xD;
             have been determined to be stable by the Trauma Service (General Surgery) and are no&#xD;
             longer within the resuscitation phase of initial treatment. This is defined as a&#xD;
             normal urine output (greater than 0.5 ml/kg/hr) and a systolic blood pressure greater&#xD;
             than 90 mmHg for greater than 6 hours without fluid bolus or transfusion during that&#xD;
             time&#xD;
&#xD;
          -  Age 18-50&#xD;
&#xD;
          -  Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant ( urine pregnancy test will be done as standard of care)&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  Head injury (Glasgow Coma Scale less than 8 over 48 hours from presentation)&#xD;
&#xD;
          -  Known cardiac (coronary artery disease, atrial fibrillation, stent placement,&#xD;
             congestive heart failure), renal (acute or chronic renal insufficiency or failure,&#xD;
             defined as having Serum Creatinine &gt;1.2 at time of enrollment), liver (Childs C&#xD;
             cirrhosis) or pulmonary disease (chronic obstructive pulmonary disease, abnormal&#xD;
             pulmonary function tests or history of poor pulmonary function from any cause&#xD;
             including acute traumatic conditions such as ARDS)&#xD;
&#xD;
          -  Unlikely to follow up in the surgeon's estimation&#xD;
&#xD;
          -  Sickle Cell Anemia&#xD;
&#xD;
          -  History of cancer&#xD;
&#xD;
          -  Preexisting weakness, paresthesias, deformities, or other conditions which might&#xD;
             affect functional outcome in the surgeon's opinion&#xD;
&#xD;
          -  Spinal cord injury&#xD;
&#xD;
          -  Patients with burns expected to require operative treatment&#xD;
&#xD;
          -  COVID positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian H Mullis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>June 6, 2023</results_first_submitted>
  <results_first_submitted_qc>June 28, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2023</results_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Brian Mullis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT02972593/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited based on physician referral at 3 level 1 trauma centers between March 2014 and May 2021. The first patient was enrolled on March 11, 2014 and the last participant was enrolled on May 7, 2021.</recruitment_details>
      <pre_assignment_details>Screening/IC done on 161 patients with a Hgb of ≤9g/dL or whose Hgb was expected to drop below 9g/dL with planned procedures/continued (controlled) bleeding. Randomization assignment occurred once patient's Hgb dropped below 7g/dL. Out of the 161 patient that consented, there were 61 whose Hgb did not drop below 7g/dL and randomization was not performed on. Those 61 patients were considered screen failures, leaving 100 patients who were randomized to either liberal or conservative transfusion.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Liberal</title>
          <description>Blood and blood products for transfusion. Transfusion will be done to keep Hgb &gt;7 g/dL.&#xD;
Blood and blood products for transfusion: Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb &gt;7 g/dL.</description>
        </group>
        <group group_id="P2">
          <title>Conservative</title>
          <description>Blood and blood products for transfusion. Transfusion will be done to keep Hgb &gt; 5.5 g/dL.&#xD;
If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One hundred patients were enrolled and randomized; however, it was noted the day after enrollment for a patient in the liberal group that the patient should not have been enrolled due to a creatinine higher than allowed by the exclusion criteria. The patient was immediately removed from the study and not included in the statistical analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Liberal Transfusion</title>
          <description>Transfusion will be done to keep Hgb &gt;7 g/dL.</description>
        </group>
        <group group_id="B2">
          <title>Conservative Transfusion</title>
          <description>Transfusion will be done to keep Hgb &gt; 5.5 g/dL.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="99"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection</title>
        <description>Deep infection is defined as the need for intravenous antibiotics and/or a return to surgery for debridement. Superficial infection is defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only.</description>
        <time_frame>one year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liberal</title>
            <description>Transfusion will be done to keep Hgb &gt;7 g/dL.</description>
          </group>
          <group group_id="O2">
            <title>Conservative</title>
            <description>Transfusion will be done to keep Hgb &gt; 5.5 g/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection</title>
          <description>Deep infection is defined as the need for intravenous antibiotics and/or a return to surgery for debridement. Superficial infection is defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Data collapsed to participant level, creating an ever/never response for each participant for each infection outcome type. Analyses performed at the participant level to determine if proportion of outcome types were similar between transfusion groups using Fisher's Exact tests, due to small expected cell counts, using SAS v9.4 (SAS Institute, Cary, NC). Power analyses performed based on these proportions using bootstrapping methods in SAS and confirmed with nQuery v8.7.1.0.</non_inferiority_desc>
            <p_value>.0122</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Combined Secondary Outcomes</title>
        <description>Combined (any) Secondary Outcomes: pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death.</description>
        <time_frame>one year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Liberal</title>
            <description>Transfusion will be done to keep Hgb &gt;7 g/dL.&#xD;
Blood and blood products for transfusion: Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb &gt;7 g/dL.</description>
          </group>
          <group group_id="O2">
            <title>Conservative</title>
            <description>Transfusion will be done to keep Hgb &gt; 5.5 g/dL.&#xD;
If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Combined Secondary Outcomes</title>
          <description>Combined (any) Secondary Outcomes: pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.7742</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Musculoskeletal Function Assessment</title>
        <description>The Musculoskeletal Function Assessment (MFA) evaluates the health status of patients with musculoskeletal disorders of the extremities, including patients with fractures and soft tissue injuries, repetitive motion disorders, osteoarthritis or rheumatoid arthritis. It describes patient functioning, assesses outcomes of surgical interventions and clinical trials, and monitors patients' functional status over time. The MFA is scored from 0 to 100 with 0 representing no dysfunction. Higher MFA scores/values represent a higher levels of dysfunction or worse outcome.</description>
        <time_frame>one year</time_frame>
        <population>Sixty five patients completed 1 year follow up but 5 declined to complete the MFA, leaving sixty patients that completed 1 year MFA.</population>
        <group_list>
          <group group_id="O1">
            <title>Liberal</title>
            <description>Transfusion will be done to keep Hgb &gt;7 g/dL.</description>
          </group>
          <group group_id="O2">
            <title>Conservative</title>
            <description>Transfusion will be done to keep Hgb &gt; 5.5 g/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Musculoskeletal Function Assessment</title>
          <description>The Musculoskeletal Function Assessment (MFA) evaluates the health status of patients with musculoskeletal disorders of the extremities, including patients with fractures and soft tissue injuries, repetitive motion disorders, osteoarthritis or rheumatoid arthritis. It describes patient functioning, assesses outcomes of surgical interventions and clinical trials, and monitors patients' functional status over time. The MFA is scored from 0 to 100 with 0 representing no dysfunction. Higher MFA scores/values represent a higher levels of dysfunction or worse outcome.</description>
          <population>Sixty five patients completed 1 year follow up but 5 declined to complete the MFA, leaving sixty patients that completed 1 year MFA.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" spread="21.1"/>
                    <measurement group_id="O2" value="28.2" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.1443</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Liberal</title>
          <description>Transfusion will be done to keep Hgb &gt;7 g/dL.</description>
        </group>
        <group group_id="E2">
          <title>Conservative</title>
          <description>Transfusion will be done to keep Hgb &gt; 5.5 g/dL.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Transfusion-related acute lung injury (TRALI)</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Secondary DVT</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Significant loss to follow up; Significant resistance by multiple providers at each site to allow conservative treatment algorithm (as most felt liberal was standard of care); Slow enrollment; No funding</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Brian H. Mullis</name_or_title>
      <organization>Indiana University School of Medicine Department of Orthopaedic Surgery</organization>
      <phone>317-963-1966</phone>
      <email>bmullis@iupui.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02972593
org study id: 1402557771
nct id: NCT02972593
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if there is a difference in outcomes between
      liberal transfusion (transfusing when hemoglobin drops below a set higher value number) and
      conservative transfusion (transfusing when hemoglobin drops below a set lower value number).
Transfusion of Orthopaedic trauma patients is routinely done in asymptomatic individuals as
      there is no accepted national standard or recommendations from the American Academy of
      Orthopaedic Surgeons or the Orthopaedic Trauma Association for what level of anemia is
      appropriate in an asymptomatic patient. Individual practitioners typically make this decision
      based on anecdotal experiences and expert opinion. No prospective study has been performed to
      date to answer this question in this patient population.

      The null hypothesis of this proposed pilot study is that no difference will be seen with a
      liberal transfusion strategy to keep a patient's hemoglobin above 7 g/dL versus a
      conservative strategy to keep the patient's hemoglobin above 5.5 g/dL in patients
      asymptomatic at rest. The primary outcome of this pilot study will be infection; defined as
      postoperative wound infection (superficial or deep) or other perioperative infection but not
      surgical site (urinary tract infection or pneumonia). Deep infection is defined as the need
      for intravenous antibiotics or a return to surgery for debridement. Superficial infection is
      defined as the use of oral antibiotics only successfully treat a surgical site infection.
      Secondary outcomes will include pulmonary embolism, deep venous thrombosis, acute renal
      failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve
      palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death, and the
      musculoskeletal functional assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative Wound Infection (Superficial or Deep) or Other Perioperative Infection
time frame: one year
description: Deep infection is defined as the need for intravenous antibiotics and/or a return to surgery for debridement. Superficial infection is defined as clinical diagnosis of cellulitis or other superficial infection treated with oral antibiotics only.
measure: Combined Secondary Outcomes
time frame: one year
description: Combined (any) Secondary Outcomes: pulmonary embolism, deep venous thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death.
measure: Musculoskeletal Function Assessment
time frame: one year
description: The Musculoskeletal Function Assessment (MFA) evaluates the health status of patients with musculoskeletal disorders of the extremities, including patients with fractures and soft tissue injuries, repetitive motion disorders, osteoarthritis or rheumatoid arthritis. It describes patient functioning, assesses outcomes of surgical interventions and clinical trials, and monitors patients' functional status over time. The MFA is scored from 0 to 100 with 0 representing no dysfunction. Higher MFA scores/values represent a higher levels of dysfunction or worse outcome.
arm group label: Liberal
arm group type: Other
description: Blood and blood products for transfusion. Transfusion will be done to keep Hgb >7 g/dL.
arm group label: Conservative
arm group type: Other
description: Blood and blood products for transfusion. Transfusion will be done to keep Hgb > 5.5 g/dL.
intervention type: Biological
intervention name: Blood and blood products for transfusion
description: Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb >7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.
arm group label: Conservative
arm group label: Liberal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Brian H Mullis, MD
role: Principal Investigator
affiliation: Indiana University
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Brian Mullis
investigator title: Principal Investigator
mesh term: Anemia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Significant loss to follow up; Significant resistance by multiple providers at each site to allow conservative treatment algorithm (as most felt liberal was standard of care); Slow enrollment; No funding
point of contact: 