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

Phase 2

Not yet recruiting

• Conditions: Surgery; Bleeding; Cardiac Disease
• Interventions: Drug: FEIBA; Drug: FFP

• Registration Number: NCT07032792
• Lead Sponsor: Northwell Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-21
• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2028-06
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FEIBA	FEIBA	-
FFP	FFP	-

Primary Outcome Measures

Name	Time	Method
Total post-treatment pRBC transfusion within 24 hours of surgery	24 hours

Secondary Outcome Measures

Name	Time	Method
Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery	24 hours
Total units of FEIBA given within 24 hours of surgery	24 hours
Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery	24 hours
Total pRBC transfusion after administration of study drug	From time of administration of study drug until time of discharge or up to 3 months, whichever comes first.
Total units of posttreatment platelet transfusion within 24 hours of surgery	24 hours
Total mLs of chest tube output within 12 hours of surgery	12 hours	This is being assessed as chest tube output may be an indicator of ongoing bleeding
Incidence of adverse postoperative events	Perioperative	This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.
Length of intubation	Perioperative
Length of hospital stay	From date of hospital admission until date of discharge or up to 3 months, whichever comes first.
30-day mortality	30 days

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States