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Fibrinogen Concentrate vs Cryoprecipitate
Not Recruiting
Trial ID: NCT03014700
Purpose
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.
Official Title
Repurposing of Fibrinogen Concentrate as a Cost-Effective and Safe Hemostatic Agent in Infants Undergoing Cardiac Surgery on Cardiopulmonary Bypass
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pre-existing coagulopathy, including unexplained bleeding or history of clotting
Intervention(s):
biological: Fibrinogen Concentrate
biological: Cryoprecipitate
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Glyn D Williams, MBChB, FFA
650-723-5728