Blood Conservation in Cardiac Surgery

Withdrawn before enrolling · Not applicable

Conditions studied: Transfusion Reactions, Post Cardiac Surgery

In brief

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

Key facts

Study ID

NCT01463345

Run by

Hackensack Meridian Health

People needed

0

Starts

2011-11-01

Expected to finish

2013-05-01

Last updated by the study team

2018-07-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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