Blood Conservation in Cardiac Surgery

Sponsor

Hackensack Meridian Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01463345

Collaborator

Rutgers, The State University of New Jersey (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Transfusion Reactions Post Cardiac Surgery	Other: Blood transfusion Other: Blood transfusion	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Blood Conservation in Cardiac Surgery

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

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. [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

Rate of incidence of transfusion related complications between the two randomizations arms. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601

Sponsors and Collaborators

Hackensack Meridian Health
Rutgers, The State University of New Jersey

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