Blood Conservation in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01463345
Recruitment Status : Terminated (PI left and closed study at Hackensack went to RUTGERS - Robert Wood Johnson Medical Center)
First Posted : November 1, 2011
Last Update Posted : February 4, 2014
Rutgers-RWJ Medical Center
Information provided by (Responsible Party):
Hackensack University Medical Center

Brief Summary:
The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based transfusion triggers in patients post cardiac surgery.

Condition or disease Intervention/treatment Phase
Transfusion Reactions Post Cardiac Surgery Other: Blood transfusion Not Applicable

Detailed Description:

Nearly 20% of blood transfusions in the United States are given to in patients undergoing cardiac surgery. Despite the many blood conservation techniques that are available, safe, and efficacious for patients, many of these operations continue to be associated with significant amounts of blood usage. We believe that transfusion protocols which employ specific guidelines for transfusion can decrease blood product usage and improve outcomes for patients undergoing cardiac surgery. Our goal is to demonstrate that a carefully chosen trigger can achieve better outcomes.

Our hypothesis is that a transfusion trigger of Hgb 7.5 g/dl will lead to decreased utilization of blood transfusions and will have many positive effects on the patients post cardiac surgery in addition to substantial cost savings. We will use an evidence based approach to observe the relative safety of a conservative transfusion trigger (7.5 g/dl) as compared to a more liberal trigger (9.0 g/dl). We will also study the effect of blood conservation on the incidence of transfusion-related complications such as transfusion related lung injury (TRALI) and infectious complications as well as length of hospital stay, cost and ventilator time.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Blood Conservation in Cardiac Surgery
Study Start Date : November 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Conservative Transfusion Arm
Subjects in the conservative transfusion arm will receive transfusion only when their hemoglobin levels reach 7.5 g/dl.
Other: Blood transfusion
Conservative transfusion arm: Subjects randomized to the conservative transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 7.5 g/dl. Blood products should be given to maintain Hgb levels >7.5 g/dl.

Active Comparator: Liberal Transfusion Arm
Subjects in the liberal transfusion arm will receive transfusion only when their hemoglobin levels reach 9.0 g/dl.
Other: Blood transfusion
Liberal transfusion arm: Subjects randomized to the liberal transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 9.0 g/dl. Blood products should be given to maintain Hgb levels > 9.0 g/dl.

Primary Outcome Measures :
  1. Safety of the lower hemoglobin transfusion trigger of 7.5 g/dl against the higher hemoglobin transfusion trigger of 9.0 g/dl. [ Time Frame: The assessment will last untill day 4 post surgery ]
    This outcome measure is a simultaneous assessment of the multiple end points duration of pressor use, symptomatic anemia, anemia-associated hypotension within 48 hours post surgery and Hgb recovery by day 4 post-surgery.

Secondary Outcome Measures :
  1. Rate of incidence of transfusion related complications between the two randomizations arms. [ Time Frame: This will be compared during the hospital stay, untill 30 days after discharge. ]
    The comparison will be based on a composite end point consisting of transfusion related lung injury (TRALI) that is ARDS, ventilator time>24 hours, pneumonia; stroke (permanent/transient); MI and renal failure.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects who meet all of the following criteria will be considered for inclusion in this study:

  1. Subjects scheduled to undergo any of the following cardiac surgeries as part of their routine medical care:

    • CABG
    • AVR
    • MVR
    • MV Repair
    • CABG/AVR
    • CABG/MVR
    • CABG/MV Repair
    • Thoracic Aneurysm Repair ± any concomitant cardiac procedure (valve, CABG, etc.)
  2. Subjects must be > 18 years of age
  3. No prior history of cardiac surgery.
  4. Able and willing to give informed consent

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participation in this study:

  1. Prior history of cardiac surgery
  2. Patients who do not have sufficient time prior to surgery to give proper informed consent (i.e.: immediate, emergency surgery)
  3. Patients who are younger than 18 years of age
  4. Prior history of

    • bleeding disorders
    • symptomatic anemia (i.e. persistent tachycardia, orthostatic hypotension, persistent pressor requirement)
    • hereditary/acquired coagulopathy
    • platelet defects (e.g.: disseminated intravascular coagulation (DIC), hemophilia, Henoch-Schönlein purpura, hereditary hemorrhagic telangiectasia, thrombocytopenia (ITP, TTP), thrombophilia, Von Willebrand's disease)
  5. History of leukemia or any other blood related malignancy
  6. History of liver failure
  7. Current, or history of, pre-existing medical condition other than current cardiac condition, which in the opinion of the investigator, would place the subject at risk or have the potential to confound interpretation of the study results
  8. Participation in another clinical trial
  9. Lack of capacity to give informed consent.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01463345

United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack University Medical Center
Rutgers-RWJ Medical Center
Principal Investigator: Leonard Lee, M.D. Dr Lee is leaving Hackensack University Medical Center on June 30th, 2012. Effective July 1st, 2012 he will assume his new role as the Chief of Cardiothoracic Surgery Division at the University OF Medicine & Dentistry OFNew Jersey-Robert Wood Johnson

Responsible Party: Hackensack University Medical Center Identifier: NCT01463345     History of Changes
Other Study ID Numbers: Pro00001949
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Hackensack University Medical Center:
Blood conservation
Hemoglobin trigger
Transfusion trigger
Cardiac surgery
Transfusion triggers post cardiac surgery

Additional relevant MeSH terms:
Transfusion Reaction
Hematologic Diseases
Immune System Diseases