- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00176657
The Use of HEMOBAG to Salvage Blood After Cardiac Surgery
Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass
Study Overview
Status
Conditions
Intervention / Treatment
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.
Following cardiopulmonary bypass (CPB), blood remaining within the bypass machine circuit is normally processed by a centrifugal separation of fluids from red blood cells (RBCs) and the RBCs are reinfused back into the patient. An FDA approved device, the HemobagTM, provides an alternative by reinfusing whole blood, including RBCs, from the CPB machine circuit. This allows the patient's own whole blood to be returned back to the patient with all components including functioning, non-activated platelets, coagulation factors and plasma. In preliminary human trials, blood measurements were improved in patients whose CPB blood was processed through the HemobagTM.
This study will evaluate 50 patients whose post-CPB blood is processed by normal practice (centrifugal separation of RBCs for reinfusion) or HemobagTM whole blood reinfusion. Outcome measurements will be chest tube drainage for the initial 24 hours following on-pump cardiac surgery, ventilatory requirements, protein levels, transfusion requirements, coagulation profile, A/A gradients, arterial blood gas measures, and CBC blood panels. All of these data are available from the normal clinical care of the patient.
The hypothesis is that the HemobagTM treated patients will have improved physiologic function from the return of whole blood rather than just RBCs following cardiac surgery using CPB.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New Jersey
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Newark, New Jersey, United States, 07103
- UMDNJ
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Hematology value
|
Days of hospital stay
|
Secondary Outcome Measures
Outcome Measure |
---|
Complication rate
|
Patient's morbidity
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Douglas J Jackson, MD, UMDNJ Dept. of Anesthesiology
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0120040166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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