Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery

Launched by NORTHWELL HEALTH · Jun 18, 2025

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ClinConnect Summary

This clinical trial is studying two different treatments for bleeding that can happen after certain types of heart surgery. When patients have heart surgery using a machine to help their heart and lungs (called cardiopulmonary bypass), bleeding caused by problems with blood clotting is common and can lead to complications. The study is comparing a medication called FEIBA to the usual treatment, which is fresh frozen plasma (FFP), to see which one works better at stopping this kind of bleeding.

Adults aged 18 and older who are having planned heart surgery (but not emergency surgery or certain types like bypass surgery) and who experience bleeding that needs treatment with clotting factors might be able to join. People who have certain blood clotting problems, severe allergies to FEIBA, or other specific health issues would not be eligible. If you participate, the care team will give you either FEIBA or FFP as the first treatment to help control bleeding after surgery, and your progress will be carefully monitored. This study aims to find safer and more effective ways to manage bleeding after heart surgery to improve recovery and outcomes.

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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 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 disorders
• • Patients who received coronary artery bypass surgery
• • Patients who received transplants or ventricular assist devices
• • Patients on extracorporeal membrane oxygenator support
• • Patients with heparin induced thrombocytopenia
• • Patients who do not wish to receive blood products even when it is deemed medically necessary