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The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass

This study is currently recruiting participants.
Verified October 2011 by Maine Medical Center
Sponsor:
Collaborator:
Global Blood Resources, LLC
Information provided by (Responsible Party):
Robert Kramer, MD, Maine Medical Center
ClinicalTrials.gov Identifier:
NCT01435304
First received: September 9, 2011
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

This proposal is designed to mitigate hemodilution (blood diluted with an electrolyte solution) and loss of plasma proteins responsible for normal blood clotting as well as platelets at the completion of cardiopulmonary bypass (CPB). The Hemobag® system is a device qualified by the US Food and Drug Administration (FDA). Many cardiac centers, such as Englewood Hospital and Medical Center in Englewood NJ are using the Hemobag® system for Jehovah's witnesses and other patients who go to that center for bloodless cardiac surgery (cardiac surgery performed without the use of blood or blood products). The system is designed to filter excessive water from blood left in the heart lung machine (cardiopulmonary bypass) after it is separated from the patient during the performance of cardiac surgery. Consequently the likelihood of excessive post-operative bleeding and transfusion with allogeneic blood (blood bank blood from donors) is decreased.


Condition Intervention Phase
Blood Coagulation Disorders
 Device: method of returning residual CPB blood ( Hemobag®)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • Chest catheter drainage [ Time Frame: Total amount for the first 24 hours postoperative ] [ Designated as safety issue: No ]
    Chest catheters are placed in the mediastinum and sometimes pleural space(s) to collect shed mediastinal blood in the first 24 hours post operative cardiac surgery


Secondary Outcome Measures:
  • Blood products transfused (RBC's, platelets, FFP) [ Time Frame: All blood products transfused during index admission, an expected average of 7 days, with the exception of preoperative transfusions. ] [ Designated as safety issue: No ]
    These blood components can be a metric of the success of achieving a satisfactory coagulation status.

  • Acute kidney injury (AKI) [ Time Frame: All creatinines will be recorded and assessed during the entire index admission in order to compare postoperative to preoperative baseline creatinine, an expected average of 7 days. ] [ Designated as safety issue: No ]
    Using the AKIN definition (Acute Kidney Injury Network), serial postoperative creatinines will reflect the presence of AKI when compared with the baseline creatinine.

  • Mortality [ Time Frame: 30 days postoperative ] [ Designated as safety issue: No ]
    Patients will be followed for 30 days post operative

  • Stroke [ Time Frame: Index admission postoperative until the time of discharge, an expected average of 7 days. ] [ Designated as safety issue: No ]
    Any neurological defect according to Society of Thoracic Surgery (STS) definition

  • Vasoactive drugs [ Time Frame: Any intravenous vasoactive drug being used at the 48 hour time point postoperative ] [ Designated as safety issue: No ]
    This metric is a surrogate for low output failure and /or vasoplegia depending upon whether inotropes or vasoconstrictors are used.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemobag®
Hemobag® method of returning residual CPB blood (study group)
 Device: method of returning residual CPB blood ( Hemobag®)
The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB).
Other Name: Hemobag®
No Intervention: cell saver
Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All adult cardiac surgery patients (age 18 or older) Cardiopulmonary bypass

Exclusion Criteria:

Patients under age 18 Off pump surgery

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435304

Contacts
Contact: Robert Kramer, MD 2076622414 kramer@mmc.org
Contact: Jane Conner-Kane, RN 2076626991 kanejan@mmc.org

Locations
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Robert Kramer, MD     207-662-2414     kramer@mmc.org    
Principal Investigator: Robert Kramer, MD            
Sponsors and Collaborators
Maine Medical Center
Global Blood Resources, LLC
Investigators
Principal Investigator: Robert Kramer, MD Maine Medical Center
  More Information

No publications provided

Responsible Party: Robert Kramer, MD, Director of Research and Quality Improvement Division of Cardiothoracic Surgery, Maine Medical Center
ClinicalTrials.gov Identifier: NCT01435304     History of Changes
Other Study ID Numbers: IRB # 3914
Study First Received: September 9, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 16, 2013