In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)

NCT ID: NCT03932240

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2021-11-16

Brief Summary

This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass to develop effective and safe strategies for managing coagulopathies in neonates.

Detailed Description

This study is a prospective, randomized control trial comparing two different sources of fibrinogen on clot kinetics (degradation and structure) in post-CPB coagulopathy in neonates undergoing cardiac surgery. The two sources of fibrinogen include the blood product, cryoprecipitate, and a blood product alternative, fibrinogen concentrate. Cryoprecipitate is an allogenic blood product that requires cross-matching and thawing prior to administration and is associated with immunologic reactions and possible pathogen transmission. Fibrinogen concentrate, a blood product alternative, is a purified form of fibrinogen, which undergoes a pasteurization process to minimize the risk of immunologic and allergic reactions. The primary aim of this study is compare the in vivo effect of post-CPB administration of FC, a blood product alternative, to cryoprecipitate on neonatal clot properties and clinical outcomes.

Conditions

Hemostasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fibrinogen Concentrate (FC)

Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and FC after separation from bypass. The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.

If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.

Group Type: EXPERIMENTAL

Fibrinogen Concentrate (FC)

Intervention Type: DRUG

The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.

Cryoprecipitate

Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who are randomized to receive platelets and cryoprecipitate. Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL (based on findings by Downey et al., published in Anesthesia and Analgesia in 2020).

If a patient in either arm continues to have post-bypass bleeding, the anesthesiologist will use point of care testing and the transfusion thresholds outlines in the transfusion algorithm to determine appropriate products for transfusion.

Group Type: ACTIVE_COMPARATOR

Cryoprecipitate

Intervention Type: DRUG

The standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL.

Interventions

Fibrinogen Concentrate (FC)

The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.

Intervention Type: DRUG

Cryoprecipitate

The standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 286mg/dL.

Intervention Type: DRUG

Other Intervention Names

RiaSTAP

Eligibility Criteria

Inclusion Criteria

1. Full term neonates (36-42 weeks gestational age)

2. Infants =< 30 days of age at time of surgery

3. APGAR score of 6 or greater at 5 minutes after delivery

4. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of Atlanta

5. Parents willing to participate and able to understand and sign the provided informed consent

Exclusion Criteria

1. Preterm neonates (less than 36 weeks gestation)

2. Patients undergoing an emergent procedure or surgery not requiring CPB

3. Patients with personal or family history of a coagulation defect or coagulopathy

4. Parents unwilling to participate or unable to understand and sign the provided informed consent

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Laura A Downey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Downey, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta (CHOA), Egleston

Atlanta, Georgia, United States

Countries

United States

References

Downey LA, Moiseiwitsch N, Nellenbach K, Xiang Y, Brown AC, Guzzetta NA. Effect of In Vivo Administration of Fibrinogen Concentrate Versus Cryoprecipitate on Ex Vivo Clot Degradation in Neonates Undergoing Cardiac Surgery. Anesth Analg. 2025 Aug 1;141(2):240-251. doi: 10.1213/ANE.0000000000007123. Epub 2024 Aug 8.

Reference Type: DERIVED

PMID: 39116012 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB00109310

Identifier Type: -

Identifier Source: org_study_id