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FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

NCT05020483 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-12-05

No results posted yet for this study

Summary

The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.

Conditions

  • Cardiac Disease

Interventions

DRUG

FEIBA

Administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. Three small doses, 5 mg/kg each, will be available.

DRUG

Placebo

Contains no active ingredient and administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously.

Sponsors & Collaborators

Principal Investigators

  • Elena Ashikhmina, MD, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05020483 on ClinicalTrials.gov