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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932240
Recruitment Status Suspended (All subject enrollment/follow up is on hold due to COVID-19 pandemic)
First Posted April 30, 2019
Last update posted May 1, 2020
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.
This study is a prospective, randomized control trial comparing two different sources of fibrinogen on clot kinetics (degradation time, structure, strength and polymerization) 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.
|Experimental: Fibrinogen Concentrate (FC)
After separation from bypass, patients will receive platelets and FC. 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.
Drug: Fibrinogen Concentrate (FC)
The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.
|Active Comparator: Cryoprecipitate
After separation from bypass, patients will receive platelets and cryoprecipitate. Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL. 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.
Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL
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1. Full term neonates (36-42 weeks gestational age)
2. Infants =< 30 days of age 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
United States, Georgia
Children's Healthcare of Atlanta (CHOA), Egleston
Principal Investigator: Laura Downey, MD Emory University