The Use of HEMOBAG to Salvage Blood After Cardiac Surgery

April 27, 2007 updated by: University of Medicine and Dentistry of New Jersey

Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass

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™.

Study Overview

Status

Terminated

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

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Hematology value
Days of hospital stay

Secondary Outcome Measures

Outcome Measure
Complication rate
Patient's morbidity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Global Blood Resources, LLC

Investigators

  • Principal Investigator: Douglas J Jackson, MD, UMDNJ Dept. of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 1, 2007

Last Update Submitted That Met QC Criteria

April 27, 2007

Last Verified

April 1, 2007

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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