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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, FEIBA and FFP, to determine which better stops bleeding in patients after heart surgery. It focuses on patients who bleed due to blood clotting issues after using a heart-lung machine during surgery. Participants should be undergoing planned heart surgery, excluding coronary artery procedures, and require treatment with clotting factors for their bleeding. The goal is to determine if FEIBA can more effectively control this type of bleeding compared to the current standard treatment, FFP (fresh frozen plasma). As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that FEIBA is generally safe in various treatment situations. In previous studies, very few side effects were reported—less than 0.04% of cases. Importantly, no blood clot problems occurred. This suggests that FEIBA is well-tolerated for treating bleeding issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

FEIBA is unique because it is designed to manage bleeding by enhancing the clotting process in patients with hemophilia who have inhibitors. Unlike standard treatments like Fresh Frozen Plasma (FFP), which rely on providing the body with general clotting factors, FEIBA specifically targets and bypasses the inhibitors that often complicate hemophilia treatment. Researchers are excited because this targeted approach can potentially offer faster and more effective bleeding control, reducing the risk of complications associated with hemophilia.

What evidence suggests that this trial's treatments could be effective for coagulopathic-induced bleeding?

Research has shown that FEIBA, one of the treatments studied in this trial, effectively treats bleeding problems. In one study, it successfully stopped bleeding in 92% of cases with sudden bleeding. Another study found that FEIBA reduced the number of bleeding episodes in patients. These results suggest that FEIBA could be a good option for managing bleeding after heart surgery. The evidence supports its potential effectiveness in these situations. Participants in this trial will receive either FEIBA or FFP, with FFP serving as the active comparator. ^{1 3 5 6 7}

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+

Citations

1. feiba.com feiba.com/us/hcp/about/efficacy-data

Efficacy Data - FEIBA [Anti-Inhibitor Coagulant Complex ... In a clinical trial, FEIBA prophylaxis delivered a reduction in median Annual Bleed Rate (ABR) compared with on-demand treatment · No Bleeding Events in 18%.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22103429/

Efficacy of FEIBA for acute bleeding and surgical ... FEIBA was judged effective in 92% of treatment courses for acute bleeding, with a 95% confidence interval (CI) of 85-97%. Rates of haemostatic efficacy did not ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S000649711985396X

“FEIBA Global Outcome Study (FEIBA GO)” Data Read-out: ... Conclusions: These preliminary findings demonstrate prevention of joint bleeding with FEIBA prophylaxis comparable to that reported in patients ...

4. ashpublications.org ashpublications.org/blood/article/109/2/546/23485/A-randomized-comparison-of-bypassing-agents-in

the FEIBA NovoSeven Comparative (FENOC) Study | Blood Both products were associated with an efficacy rate of from 80% to 90% at some time points, consistent with previous reports.11-13,17 Another ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1104435

Anti-Inhibitor Coagulant Complex Prophylaxis in ... Panel B shows the data on bleeding for the 10 patients in whom bleeding episodes were reduced by less than 50% during prophylaxis. A mean of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16834734/

A retrospective postlicensure survey of FEIBA efficacy and ... Based on available data, FEIBA was judged safe in all treatment situations by the small number of adverse events (<0.04%). No thrombotic complications occurred ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29802004/

Safety and Effectiveness of Factor Eight Inhibitor Bypassing ... This case series suggests that FEIBA administration is relatively safe and effective to reverse DOACs in the setting of hemorrhage or need for urgent surgical ...