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Blood Conservation in Cardiac Surgery

Primary Purpose

Transfusion Reactions, Post Cardiac Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood transfusion
Blood transfusion
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transfusion Reactions focused on measuring Blood conservation, Transfusion, Hemoglobin trigger, Transfusion trigger, Cardiac surgery, Transfusion triggers post cardiac surgery

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hackensack University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conservative Transfusion Arm

Liberal Transfusion Arm

Arm Description

Subjects in the conservative transfusion arm will receive transfusion only when their hemoglobin levels reach 7.5 g/dl.

Subjects in the liberal transfusion arm will receive transfusion only when their hemoglobin levels reach 9.0 g/dl.

Outcomes

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.
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.
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.

Full Information

First Posted
October 27, 2011
Last Updated
July 20, 2018
Sponsor
Hackensack Meridian Health
Collaborators
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01463345
Brief Title
Blood Conservation in Cardiac Surgery
Official Title
Blood Conservation in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI left and closed study at Hackensack went to RUTGERS
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
Collaborators
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transfusion Reactions, Post Cardiac Surgery
Keywords
Blood conservation, Transfusion, Hemoglobin trigger, Transfusion trigger, Cardiac surgery, Transfusion triggers post cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative Transfusion Arm
Arm Type
Experimental
Arm Description
Subjects in the conservative transfusion arm will receive transfusion only when their hemoglobin levels reach 7.5 g/dl.
Arm Title
Liberal Transfusion Arm
Arm Type
Active Comparator
Arm Description
Subjects in the liberal transfusion arm will receive transfusion only when their hemoglobin levels reach 9.0 g/dl.
Intervention Type
Other
Intervention Name(s)
Blood transfusion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood transfusion
Intervention Description
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 Measure Information:
Title
Safety of the lower hemoglobin transfusion trigger of 7.5 g/dl against the higher hemoglobin transfusion trigger of 9.0 g/dl.
Description
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.
Time Frame
The assessment will last untill day 4 post surgery
Secondary Outcome Measure Information:
Title
Rate of incidence of transfusion related complications between the two randomizations arms.
Description
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.
Time Frame
This will be compared during the hospital stay, untill 30 days after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who meet all of the following criteria will be considered for inclusion in this study: 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.) Subjects must be > 18 years of age No prior history of cardiac surgery. 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: Prior history of cardiac surgery Patients who do not have sufficient time prior to surgery to give proper informed consent (i.e.: immediate, emergency surgery) Patients who are younger than 18 years of age 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) History of leukemia or any other blood related malignancy History of liver failure 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 Participation in another clinical trial Lack of capacity to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Lee, M.D.
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States

12. IPD Sharing Statement

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Blood Conservation in Cardiac Surgery

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