FEIBA and Use of Blood Products in Cardiac Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 11/8/2017 |
| Start Date: | February 2016 |
| End Date: | December 2018 |
Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized Double Blind Placebo Controlled Pilot Trial
The purpose of this pilot study is to evaluate the feasibility of the prophylactic
administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of
cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to
demonstrate the potential role of FEIBA administration in reducing the need for allogeneic
transfusion to treat refractory coagulopathy in high risk patients.
administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of
cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to
demonstrate the potential role of FEIBA administration in reducing the need for allogeneic
transfusion to treat refractory coagulopathy in high risk patients.
Factor eight inhibitor bypassing activity (FEIBA) is currently approved for use in this
country for the treatment of patients with Hemophilia and inhibitors at a dose of 50-100
units/kg. There is a large body of evidence demonstrating the safety and efficacy of FEIBA
for Hemophilia patients with inhibitor and has a theoretical advantage compared to current
blood product transfusion methods, as it replenishes multiple depleted factors that are lost
with prolonged exposure to CPB.
This pilot study is a single center, randomized, double-blinded, placebo controlled trial
assessing the feasibility and safety of factor eight inhibitor bypass activity (FEIBA) in
patients undergoing major cardiovascular surgery requiring prolonged CPB. The study
population will consist of adult patients undergoing elective cardiac surgery at OHSU. Twelve
participants will randomly assigned to receive FEIBA or placebo during their surgical
procedure.
Patients will be followed to review for adverse events while in the ICU, and up to four weeks
after discharge.
country for the treatment of patients with Hemophilia and inhibitors at a dose of 50-100
units/kg. There is a large body of evidence demonstrating the safety and efficacy of FEIBA
for Hemophilia patients with inhibitor and has a theoretical advantage compared to current
blood product transfusion methods, as it replenishes multiple depleted factors that are lost
with prolonged exposure to CPB.
This pilot study is a single center, randomized, double-blinded, placebo controlled trial
assessing the feasibility and safety of factor eight inhibitor bypass activity (FEIBA) in
patients undergoing major cardiovascular surgery requiring prolonged CPB. The study
population will consist of adult patients undergoing elective cardiac surgery at OHSU. Twelve
participants will randomly assigned to receive FEIBA or placebo during their surgical
procedure.
Patients will be followed to review for adverse events while in the ICU, and up to four weeks
after discharge.
Inclusion Criteria:
- Age 18 or older
- Elective aortic or aortic valve procedures, coronary re-implantation (Bentall) with
cardiopulmonary bypass, and/or deep hypothermic circulatory arrest.
- Written informed consent
Exclusion Criteria:
- Contraindications to the administration of FIEBA or known anaphylactic or severe
hypersensitivity reactions to FEIBA or any of its components
- Disseminated intravascular coagulation (DIC)
- Acute thrombosis or embolism, including myocardial infarction
- Pregnant women
- Decisionally impaired adults
- Prisoners
- Expressed unwillingness or are otherwise deemed unable to provide written informed
consent.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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