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

NCT01435304 | Completed Results DMC

• 1 other identifier: IRB # 3914
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Coagulation Disorders

Outcome Measures

Primary Outcomes (1)

• Amount of Chest Catheter Drainage 24 Hours Postoperatively

  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

  Total amount for the first 24 hours postoperative

Secondary Outcomes (5)

• Number of Participants Which Had Blood Products Transfused (RBC's, Platelets, FFP)

  All blood products transfused during index admission, an expected average of 7 days, with the exception of preoperative transfusions.

• Number of Participants With Acute Kidney Injury (AKI)

  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.

• Number of Participants With a Mortality

  Index admission postoperative until the time of discharge, an expected average of 7 days.

• Number of Participants With Stroke

  Index admission postoperative until the time of discharge, an expected average of 7 days.

• Number of Participants on Vasoactive Drugs at 48 Hours Post op Point

  Any intravenous vasoactive drug being used at the 48 hour time point postoperative

Study Arms (2)

Hemobag®

EXPERIMENTAL

Hemobag® method of returning residual CPB blood (study group)

Device: method of returning residual CPB blood ( Hemobag®)

cell saver

NO INTERVENTION

Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)

Interventions

method of returning residual CPB blood ( Hemobag®) DEVICE

The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB).

Also known as: Hemobag®

Hemobag®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients under age 18 Off pump surgery

Sponsors & Collaborators

• MaineHealth: lead
• Global Blood Resources, LLC: collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Robert S Kramer
• Organization: Maine Medical Center

Kramer@mmc.com

207-662-1486

Study Officials

• Robert Kramer, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Quality Improvement Division of Cardiothoracic Surgery

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 16, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 6, 2018
• Results First Posted: May 2, 2018

Record last verified: 2018-05

Locations

US (1)