Blood Conservation in Cardiac Surgery

This study has been terminated.
(PI left and closed study at Hackensack went to RUTGERS - Robert Wood Johnson Medical Center)
Sponsor:
Collaborator:
Rutgers-RWJ Medical Center
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT01463345
First received: October 27, 2011
Last updated: February 2, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Transfusion Reactions
Post Cardiac Surgery
Other: Blood transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Blood Conservation in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 900
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463345

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Hackensack University Medical Center
ClinicalTrials.gov Identifier: NCT01463345     History of Changes
Other Study ID Numbers: Pro00001949
Study First Received: October 27, 2011
Last Updated: February 2, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Blood Group Incompatibility
Hematologic Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014