Status:
TERMINATED
The Use of HEMOBAG to Salvage Blood After Cardiac Surgery
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Global Blood Resources, LLC
Conditions:
Cardiopulmonary Bypass
Cardiac Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
Detailed Description
The HemobagTM is a bag containing a microfilter for separation of autologous whole blood from intravenous solutions to provide a whole blood reinfusion from a cardiopulmonary bypass machine. Followin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00176657
Start Date
September 1 2004
End Date
April 1 2007
Last Update
May 1 2007
Active Locations (1)
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1
UMDNJ
Newark, New Jersey, United States, 07103