The Use of HEMOBAG to Salvage Blood After Cardiac Surgery

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The avoidance of blood transfusions benefits the patient. Cardiopulmonary bypass (CPB) is routinely used in complex cardiac surgeries. This device requires circulating blood through an oxygenator and pump while the heart is stopped. Upon discontinuation of CPB, the volume of blood in the CPB circuit, approximately 1 to 1.5 liters, is currently processed for the red cell components of the blood. Yet, all the other blood components are available in this volume of blood, but are discarded. The Hemobag filters allow for whole blood reinfusion rather than just red cell reinfusion. Thus, the patient's own platelets, for example, are returned to the patient. The product is just being used clinically and we, the investigators at University of Medicine and Dentistry, New Jersey, have been asked to perform a study on our normal practice (red blood cell return as described above) compared to the whole blood return available with the Hemobag™.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: Global Blood Resources, LLC

Criteria

Inclusion Criteria:

• Males or females between the ages of 18 and 80 years of age, who are mentally capable of giving an informed consent.

• Electively scheduled cardiac or open heart surgery using the cardiopulmonary bypass pump.

Exclusion Criteria:

• Failure to provide an informed consent

• History of trans ischemic attacks (TIA) and/or stroke with residual neurological or cognitive dysfunction

• Currently on dialysis (treatment for kidneys with little or no function)

• History of impaired liver function or coagulopathy

• Hemodynamic instability, cardiogenic shock or severe cardiomegaly

• Scheduled combined surgical procedure (i.e. coronary artery bypass graft [CABG] and endarterectomy)

• If patient has received more than two units of blood in the 12 hours preceding randomization.