FEIBA vs FFP for Bleeding

Overseen By Kristine McGowan

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Coagulation disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Perioperative period

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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 versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients.

Who Is on the Research Team?

Pey-Jen Yu

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for cardiac surgery patients who experience coagulopathic-induced bleeding after the procedure. It's not clear what specific inclusion or exclusion criteria are set, so interested individuals should inquire about detailed eligibility requirements.

Inclusion Criteria

Provision of signed and dated informed consent form

I am 18 years old or older.

I need transfusions for bleeding due to small vessel issues, as my care team advises.

Exclusion Criteria

I have a low platelet count due to a reaction to heparin.

I am allergic or have had a severe reaction to FEIBA or its ingredients.

I cannot or do not want to give consent for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either FEIBA or FFP as first line therapy for coagulopathic-induced bleeding after cardiac surgery

Perioperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of adverse postoperative events

12 hours

What Are the Treatments Tested in This Trial?

Interventions

• FEIBA
• FFP

Trial Overview The study aims to compare FEIBA (Factor VIII Inhibitor Bypass Activity) with FFP (Fresh Frozen Plasma) to see which is more effective as a first-line treatment for bleeding in patients following cardiac surgery.

How Is the Trial Designed?

Group I: FEIBA Experimental Treatment 1 Intervention

Group II: FFP Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+