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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Withdrawn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

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:

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.

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

NCT ID

NCT01463345

First Posted

October 27, 2011

Last Updated

July 20, 2018

Sponsor

Hackensack Meridian Health

Collaborators

Rutgers, The State University of New Jersey

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

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

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

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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