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

Emory University

Status and phase: Completed; Phase 3

Conditions: Hemostasis

Treatments: Drug: Cryoprecipitate; Drug: Fibrinogen Concentrate (FC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03932240

IRB00109310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Fibrinogen Concentrate (FC)

Experimental group

Description:

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.

Treatment:

Drug: Fibrinogen Concentrate (FC)

Cryoprecipitate

Active Comparator group

Description:

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.

Treatment:

Drug: Cryoprecipitate