COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

The Use of HEMOBAG to Salvage Blood After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176657
Recruitment Status : Terminated (Inability to attain sufficient numbers of subjects)
First Posted : September 15, 2005
Last Update Posted : May 1, 2007
Global Blood Resources, LLC
Information provided by:
Rutgers, The State University of New Jersey

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™.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Bypass Cardiac Diseases Drug: HEMOBAG Assessment Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass
Study Start Date : September 2004
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. Hematology value
  2. Days of hospital stay

Secondary Outcome Measures :
  1. Patient's morbidity
  2. Complication rate

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176657

Layout table for location information
United States, New Jersey
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Global Blood Resources, LLC
Layout table for investigator information
Principal Investigator: Douglas J Jackson, MD UMDNJ Dept. of Anesthesiology
Layout table for additonal information Identifier: NCT00176657    
Other Study ID Numbers: 0120040166
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 1, 2007
Last Verified: April 2007
Keywords provided by Rutgers, The State University of New Jersey:
cardiac surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases