Fibrinogen Concentrate vs Cryoprecipitate
Fibrinogen Concentrate vs Cryoprecipitate
NCT ID: NCT03014700 Phase: PHASE4 Status: COMPLETED Enrollment: 60 Completion: 2018-04-25
Conditions
Congenital Heart Disease
Interventions
Fibrinogen Concentrate, Cryoprecipitate
Summary
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and allogenic blood transfusions.
Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen concentrate will be as effective in treating post-CPB bleeding and will decrease total blood product exposure when used as part of a blood transfusion algorithm.
We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a fibrinogen level \<250mg/dL while on bypass.
We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard of care in the management of peri- operative bleeding in neonatal patients undergoing cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as effective as the standard of care, then we would plan a multi-center trial to demonstrate the safety and efficacy of this medication. If we are able to demonstrate that fibrinogen concentrate is effective, fibrinogen concentrate could replace allogenic products and potentially decrease transfusion related morbidity in mortality in this population.
Primary Outcome
Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival.