Blood Conservation in Cardiac Surgery

Post Cardiac Surgery Clinical Trial

Official title:

Blood Conservation in Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01463345
• Other study ID #: Pro00001949
• Status: Withdrawn
• Phase: N/A
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2018
• Source: Hackensack University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post Cardiac Surgery
• Transfusion Reaction
• Transfusion Reactions

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hackensack University Medical Center	Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.