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The Use of HEMOBAG to Salvage Blood After Cardiac Surgery

Primary Purpose

Cardiopulmonary Bypass, Cardiac Diseases

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HEMOBAG Assessment
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiopulmonary Bypass focused on measuring cardiac surgery, transfusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMDNJ

Outcomes

Primary Outcome Measures

Hematology value
Days of hospital stay

Secondary Outcome Measures

Patient's morbidity
Complication rate

Full Information

First Posted
September 13, 2005
Last Updated
April 27, 2007
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Global Blood Resources, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00176657
Brief Title
The Use of HEMOBAG to Salvage Blood After Cardiac Surgery
Official Title
Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Inability to attain sufficient numbers of subjects
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Global Blood Resources, LLC

4. Oversight

5. Study Description

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™.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Bypass, Cardiac Diseases
Keywords
cardiac surgery, transfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
HEMOBAG Assessment
Primary Outcome Measure Information:
Title
Hematology value
Title
Days of hospital stay
Secondary Outcome Measure Information:
Title
Patient's morbidity
Title
Complication rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas J Jackson, MD
Organizational Affiliation
UMDNJ Dept. of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Use of HEMOBAG to Salvage Blood After Cardiac Surgery

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