FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients

NCT05020483 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 21-005539
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

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

  Number of units of transfused allogeneic blood products after cardiopulmonary bypass in the operating room (OR) and in the intensive care unit (ICU) on postoperative day (POD) 0 and 1.

  approximately 1 day postoperatively

Secondary Outcomes (3)

• Hospital length of stay

  Through hospital discharge, approximately 3 days

• Mortality

  Through hospital discharge, approximately 3 days

• Intravascular and intracardiac thromboses

  approximately 3 days postoperatively

Study Arms (2)

FEIBA Group

EXPERIMENTAL

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.

Drug: FEIBA

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

FEIBA DRUG

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.

Also known as: activated prothrombin complex concentrate (aPCC) FEIBA

FEIBA Group

Placebo DRUG

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.

Placebo Group

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Weight ≤ 15 kg.
• Elective cardiac surgery with cardiopulmonary bypass.
• Coagulopathic bleeding after cardiopulmonary bypass.
• Availability and willingness of the parent/legal guardian to provide informed consent.

You may not qualify if:

• Presence of mechanical circulatory support at the time of randomization or POD 0 and 1.
• Patient or family history of coagulopathy and/or thromboses.
• Preoperative anticoagulation (excluding low dose heparin for "line prophylaxis").

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Diseases

Interventions

anti-inhibitor coagulant complex

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Elena Ashikhmina, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-11