<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/NCT01705470</url>
  </required_header>
  <id_info>
    <org_study_id>SHERLOCK</org_study_id>
    <nct_id>NCT01705470</nct_id>
  </id_info>
  <brief_title>Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study Objective is to assess the clinical and echocardiographic changes of patients with&#xD;
      systolic dysfunction receiving blood transfusion, with or without prior treatment with&#xD;
      furosemide&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than 4 million patients receive a blood transfusion each year in the United States, many&#xD;
      of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is&#xD;
      unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition&#xD;
      of anemia in CHF.&#xD;
&#xD;
      Treating CHF patients with furosemide prior to blood transfusion became a common practice,&#xD;
      even though no randomize clinical trial had examine this issue. Nand et al. measured the&#xD;
      pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg &lt;6 mg/dl) and&#xD;
      no systemic disease before and after transfusion of 700ml of whole blood. Ten of these&#xD;
      patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion.&#xD;
      The PCWP had increased significantly among patient who did not receive the furosemide and&#xD;
      decreased by 3.75% among patients in the furosemide group, although this change was not was&#xD;
      statistically significant. In another study, the same group of Nand et al. measured the PCWP&#xD;
      among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered&#xD;
      from cardiopulmonary disease. The patients were randomly divided into 4 groups: the&#xD;
      difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min&#xD;
      and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the&#xD;
      transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3&#xD;
      groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and&#xD;
      32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP&#xD;
      decreased significantly by 21.7%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left the medical center, no replacement assigned&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment</measure>
    <time_frame>Within 4 hours from receiving the blood transfusion</time_frame>
    <description>Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical outcome following blood transfusion, with or without Furosemide treatment</measure>
    <time_frame>Within 4 hours from receiving the blood transfusion</time_frame>
    <description>clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction</condition>
  <arm_group>
    <arm_group_label>arm1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>furosemide</intervention_name>
    <arm_group_label>arm1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo normal saline</intervention_name>
    <arm_group_label>arm2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is over 18 years old.&#xD;
&#xD;
          -  Documented ejection function equal to or over 40% in prior tests&#xD;
&#xD;
          -  The treating physician decided to treat the patient with packed cell&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to furosemide.&#xD;
&#xD;
          -  Calculated creatinine clearance over 20% (by MDRD)&#xD;
&#xD;
          -  Past adverse reaction to blood product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edo Birati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel Aviv MC</affiliation>
  </overall_official>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>June 27, 2016</last_update_submitted>
  <last_update_submitted_qc>June 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Furosemide</keyword>
  <keyword>Anemia</keyword>
  <keyword>LV dysfunction</keyword>
  <keyword>blood transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction, Left</mesh_term>
    <mesh_term>Systolic Murmurs</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Furosemide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01705470
org study id: SHERLOCK
nct id: NCT01705470
lead sponsor: 
has dmc: No
The study Objective is to assess the clinical and echocardiographic changes of patients with
      systolic dysfunction receiving blood transfusion, with or without prior treatment with
      furosemide
More than 4 million patients receive a blood transfusion each year in the United States, many
      of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is
      unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition
      of anemia in CHF.

      Treating CHF patients with furosemide prior to blood transfusion became a common practice,
      even though no randomize clinical trial had examine this issue. Nand et al. measured the
      pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and
      no systemic disease before and after transfusion of 700ml of whole blood. Ten of these
      patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion.
      The PCWP had increased significantly among patient who did not receive the furosemide and
      decreased by 3.75% among patients in the furosemide group, although this change was not was
      statistically significant. In another study, the same group of Nand et al. measured the PCWP
      among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered
      from cardiopulmonary disease. The patients were randomly divided into 4 groups: the
      difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min
      and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the
      transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3
      groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and
      32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP
      decreased significantly by 21.7%.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment
time frame: Within 4 hours from receiving the blood transfusion
description: Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment
measure: clinical outcome following blood transfusion, with or without Furosemide treatment
time frame: Within 4 hours from receiving the blood transfusion
description: clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation
arm group label: arm1
arm group type: Experimental
description: will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).
arm group label: arm2
arm group type: Experimental
description: will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).
intervention type: Drug
intervention name: furosemide
arm group label: arm1
intervention type: Drug
intervention name: placebo normal saline
arm group label: arm2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Edo Birati, MD
role: Principal Investigator
affiliation: Tel Aviv MC
responsible party type: Sponsor
mesh term: Ventricular Dysfunction, Left
mesh term: Systolic Murmurs
mesh term: Furosemide
sharing ipd: No