Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fres... | NCT07032792

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

NCT07032792

Sponsor

Northwell Health

Status

Recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

140Estimated

Phase

Phase 2

Conditions

Cardiac Disease
Surgery
Bleeding

Interventions

FEIBA
FFP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2025Actual

Primary Completion Date

Nov 2028Estimated

Completion Date

Nov 2029Estimated

First Submitted Date

Apr 21, 2025

First Submission Date that Met QC Criteria

Jun 18, 2025

First Posted Date

Jun 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FEIBA	Experimental		Drug: FEIBA
FFP	Active Comparator		Drug: FFP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FEIBA	Drug	Subjects randomized to FEIBA will receive up to 2 vials of 500U of FEIBA through a preexisting central line at a rate that does not exceed 2 units per kg of body weight per minute for the study intervention.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total post-treatment pRBC transfusion within 24 hours of surgery		24 hours

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kristine McGowan	Contact	516-881-7035		kmcgowan@northwell.edu

Overall Officials

Name	Affiliation	Role
Pey-Jen Yu	Northwell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Shore University Hospital	Recruiting	Manhasset	New York	11030	United States

Condition Browse Module

MeSH Terms

ID	Term
D006331	Heart Diseases
D006470	Hemorrhage

Ancestor Terms

ID	Term
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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