Trial Search Results

Fibrinogen Concentrate vs Cryoprecipitate

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Emory University

Stanford Investigator(s):

Intervention(s):

  • Biological: Fibrinogen Concentrate
  • Biological: Cryoprecipitate

Phase:

Phase 4

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

Ages Eligible for Study

N/A - 12 Months

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Glyn D Williams, MBChB, FFA
650-723-5728
Not Recruiting