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

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ClinicalTrials.gov Identifier: NCT01435304
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : March 24, 2016
Sponsor:
Collaborator:
Global Blood Resources, LLC
Information provided by (Responsible Party):
Robert Kramer, MD, Maine Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Blood Coagulation Disorders Device: method of returning residual CPB blood ( Hemobag®) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
Study Start Date : September 2011
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Chest catheter drainage [ Time Frame: Total amount for the first 24 hours postoperative ]
    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 :
  1. 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. ]
    These blood components can be a metric of the success of achieving a satisfactory coagulation status.

  2. 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. ]
    Using the AKIN definition (Acute Kidney Injury Network), serial postoperative creatinines will reflect the presence of AKI when compared with the baseline creatinine.

  3. Mortality [ Time Frame: 30 days postoperative ]
    Patients will be followed for 30 days post operative

  4. Stroke [ Time Frame: Index admission postoperative until the time of discharge, an expected average of 7 days. ]
    Any neurological defect according to Society of Thoracic Surgery (STS) definition

  5. Vasoactive drugs [ Time Frame: Any intravenous vasoactive drug being used at the 48 hour time point postoperative ]
    This metric is a surrogate for low output failure and /or vasoplegia depending upon whether inotropes or vasoconstrictors are used.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


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 ClinicalTrials.gov identifier (NCT number): NCT01435304


Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Maine Medical Center
Global Blood Resources, LLC
Investigators
Principal Investigator: Robert Kramer, MD Maine Medical Center

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
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016

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