Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
Recruiting
Phase 2
Interventional Study
Cardiac Disease
Surgery
Bleeding
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Northwell Health · Other
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About This Trial
Coagulopathic-induced bleeding after cardiopulmonary bypass in cardiac surgery patients is common and is associated with adverse outcomes in cardiac surgery. The hypothesis of the study is that FEIBA will be a more effective treatment than standard of care (FFP) in cardiac surgery patients who have coagulopathic-induced bleeding. This study is being conducted to determine the efficacy of FEIBA ver…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 years or above
* Undergoing nonemergent non-coronary cardiac surgery with the use of cardiopulm…
Contacts