Fibrinogen Concentrate vs Cryoprecipitate
Completed · Phase 4
Conditions studied: Congenital Heart Disease
In brief
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.
Key facts
- Study ID
- NCT03014700
- Run by
- Stanford University
- People needed
- 60
- Starts
- 2016-03-01
- Expected to finish
- 2018-04-25
- Last updated by the study team
- 2019-05-07
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Neonates of at least 32 weeks of gestational age and infants up to 12 months of age with the diagnosis of congenital heart disease, requiring open heart surgery with cardiopulmonary bypass
You may not qualify if…
- Pre-existing coagulopathy, including unexplained bleeding or history of clotting
Where it is running
- Stanford University Medical Center — Stanford, California, United States
- Laura Downey — Emory, Georgia, United States
Full record on ClinicalTrials.gov
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