Status:
WITHDRAWN
Blood Conservation in Cardiac Surgery
Lead Sponsor:
Hackensack Meridian Health
Collaborating Sponsors:
Rutgers, The State University of New Jersey
Conditions:
Transfusion Reactions
Post Cardiac Surgery
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01463345
Start Date
November 1 2011
End Date
May 1 2013
Last Update
July 24 2018
Active Locations (1)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601