The Use of HEMOBAG to Salvage Blood After Cardiac Surgery

This study has been terminated.
(Inability to attain sufficient numbers of subjects)
Sponsor:
Collaborator:
Global Blood Resources, LLC
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176657
First received: September 13, 2005
Last updated: April 27, 2007
Last verified: April 2007
  Purpose

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™.


Condition Intervention Phase
Cardiopulmonary Bypass
Cardiac Diseases
Drug: HEMOBAG Assessment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Hematology value
  • Days of hospital stay

Secondary Outcome Measures:
  • Patient's morbidity
  • Complication rate

Estimated Enrollment: 50
Study Start Date: September 2004
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176657

Locations
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Global Blood Resources, LLC
Investigators
Principal Investigator: Douglas J Jackson, MD UMDNJ Dept. of Anesthesiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00176657     History of Changes
Other Study ID Numbers: 0120040166
Study First Received: September 13, 2005
Last Updated: April 27, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
cardiac surgery
transfusion

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014