Blood Conservation in Cardiac Surgery

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

Study Overview

• Status: Withdrawn
• Conditions: Post Cardiac Surgery; Transfusion Reactions
• Intervention / Treatment: Other: Blood transfusion; Other: Blood transfusion

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.; 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.
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; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The assessment will last untill day 4 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This will be compared during the hospital stay, untill 30 days after discharge.

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 27, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac surgery; Transfusion; Blood conservation; Hemoglobin trigger; Transfusion trigger; Transfusion triggers post cardiac surgery
• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: Pro00001949