The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MaineHealth
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Amount of Chest Catheter Drainage 24 Hours Postoperatively
Study Overview
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.
Detailed Description
Background:
Cardiopulmonary bypass (CPB) consists of an extracorporeal (outside of the body) circuit which allows the circulation and oxygenation of blood during cardiac surgery. The circuit includes an oxygenator, a reservoir and tubing, all of which needs to be primed with a balanced electrolyte solution. Prior to initiating CPB, the venous and arterial ends of the CPB circuit are appropriately attached to the patient. The volume of the circuit is usually 1.5 liters which is equivalent to 30-38% of a typical patient's total blood volume that is generally between 4 and 5 liters.
When CPB is initiated, the patient's blood is mixed and diluted by the CPB priming fluid. Consequently, when the operation is completed and the CPB is discontinued, the content of the CPB circuit consists of the patient's diluted whole blood. The standard practice is to return as much of this hemodiluted CPB contents as the patient will accommodate and process the rest of the contents of the circuit with a cell washer and return packed red blood cells to the patient.
When the cell washer is used, plasma proteins, clotting factors and platelets are not returned to the patient. An alternate approach would be to use an ultrafiltration device to remove this non-cellular water and preserve proteins,
clotting factors and platelets as well as red blood cells that can then be returned to the patient. This alternate approach is the basic principle of the Hemobag®, an ultrafiltration technology and method.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult cardiac surgery patients (age 18 or older) Cardiopulmonary bypass
Exclusion Criteria
- •Patients under age 18 Off pump surgery
Arms & Interventions
Hemobag®
Hemobag® method of returning residual CPB blood (study group)
Intervention: method of returning residual CPB blood ( Hemobag®) (Device)
cell saver
Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group)
Outcomes
Primary Outcomes
Amount of Chest Catheter Drainage 24 Hours Postoperatively
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 Outcomes
- 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)
- 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.)
Investigators
Robert Kramer, MD
Director of Research and Quality Improvement Division of Cardiothoracic Surgery
MaineHealth