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Clotting Factor

FEIBA for Cardiovascular Disease

Phase 2

Waitlist Available

Led By Elena Ashikhmina, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 days postoperatively

Awards & highlights

Study Summary

This trial will test if FEIBA can help stop bleeding and reduce transfusions for young heart surgery patients.

Eligible Conditions

Cardiovascular Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 days postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 days postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 days postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.

Secondary outcome measures

Hospital length of stay

Intravascular and intracardiac thromboses

Mortality

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FEIBA GroupExperimental Treatment1 Intervention

Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive activated prothrombin complex concentrate (aPCC) FEIBA to be incorporated into standard treatment of post-bypass coagulopathic bleeding.

Group II: Placebo GroupPlacebo Group1 Intervention

Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive a placebo to be incorporated into standard treatment of post-bypass coagulopathic bleeding.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FEIBA

2016

Completed Phase 3

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,208 Previous Clinical Trials

3,767,050 Total Patients Enrolled

Elena Ashikhmina, MD, PhDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential side effects may occur when using FEIBA?

"Our Power team has determined that FEIBA's safety is rated a 2, as there exists some evidence of security but no proof of efficacy yet."

Answered by AI

Is this an innovative research endeavor?

"Currently, 9 clinical trials for FEIBA are being conducted in 3 countries and across 9 cities. CSL Behring originally launched the study to gain drug approval back in 2018 with 60 participants involved. Since then, 18348 studies have been completed."

Answered by AI

What conditions does FEIBA treat most frequently?

"FEIBA is frequently employed to manage the symptoms of hemophilia b, but it has also been successful when used for prophylaxis, bleeding attributed to hemophilia a, and other related ailments."

Answered by AI

How many volunteers are actively contributing to the experiment?

"Affirmative. The information found on clinicaltrials.gov manifests that this research, first introduced to the public on October 28th 2021, is currently searching for patients. Sixty individuals are needed from 1 location."

Answered by AI

Is there still availability for individuals to join this clinical trial?

"Affirmative. The details on clinicaltrials.gov demonstrate that this medical investigation is actively seeking participants, which was first advertised on October 28th 2021 and updated lastly at the end of November 2021. This study requires a total of 60 volunteers from one site only."

Answered by AI

What additional investigations have been conducted into the usage of FEIBA?

"Presently, 9 trials are underway for FEIBA; 3 of those being in the final stages. Although Rochester, Minnesota is the primary hub for these studies, there are 13 additional sites hosting experiments with this medical intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

Elena Ashikhmina 2021. "FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020483.