Blood Conservation in Cardiac Surgery

Not Applicable

Withdrawn

• Conditions: Transfusion Reactions; Post Cardiac Surgery
• Interventions: Other: Blood transfusion

• Registration Number: NCT01463345
• Lead Sponsor: Hackensack Meridian Health

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.

Study Timeline

• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-10-31
• Study Start: 2011-11
• Study First Posted: 2011-11-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal Transfusion Arm	Blood transfusion	Subjects in the liberal transfusion arm will receive transfusion only when their hemoglobin levels reach 9.0 g/dl.
Conservative Transfusion Arm	Blood transfusion	Subjects in the conservative transfusion arm will receive transfusion only when their hemoglobin levels reach 7.5 g/dl.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States