Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line The
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-induce
| Condition(s) | Cardiac Disease, Surgery, Bleeding |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients. |
| Who can participate | 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 cardiopulmonary bypass * Patient with microvascular bleeding requiring factor transfusion as deemed by the patient care team Exclusion Criteria: * Contraindication to the administration of FEIBA or known anaphylactic or severe hypersensitivity reaction to FEIBA or any of its components * Disseminated intravascular coagulation * Acute thrombosis or embolism, including myocardial infarction * Pregnancy * Patients that are not able or do not want to consent for themselves * Patients with known coagulation dis |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Northwell Health |
| Locations | Manhasset, New York, United States |
| Start date | 2025-11-03 |
| NCT ID | NCT07032792 |
| Official listing | https://clinicaltrials.gov/study/NCT07032792 |