The Effect of the Hemobag® Ultrafiltration System on Blood Conservation and Coagulation After Cardiopulmonary Bypass
Completed · Not applicable
Conditions studied: Blood Coagulation Disorders
In brief
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.
Key facts
- Study ID
- NCT01435304
- Run by
- MaineHealth
- People needed
- 100
- Starts
- 2011-09-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2018-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Maine Medical Center — Portland, Maine, United States
Full record on ClinicalTrials.gov
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