The Use of HEMOBAG to Salvage Blood After Cardiac Surgery

NCT00176657 | Terminated Phase 2

• 1 other identifier: 0120040166
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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™.

Conditions

Cardiopulmonary Bypass; Cardiac Diseases

Keywords

cardiac surgery; transfusion

Outcome Measures

Primary Outcomes (2)

• Hematology value

• Days of hospital stay

Secondary Outcomes (2)

• Patient's morbidity

• Complication rate

Interventions

HEMOBAG Assessment DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• Global Blood Resources, LLC: collaborator

Study Sites (1)

UMDNJ

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Douglas J Jackson, MD

  UMDNJ Dept. of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2004
• Study Completion: April 1, 2007
• Last Updated: May 1, 2007

Record last verified: 2007-04

Locations

US (1)