Status:
COMPLETED
Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Octapharma
Conditions:
Pediatric HD
Bleeding
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE4
Brief Summary
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass...
Detailed Description
Once the need for fibrinogen supplementation is confirmed, study participants will be randomized into one of two treatment groups (n=15 in each group): 1. Cryoprecipitate group (dose: 10 ml/kg; activ...
Eligibility Criteria
Inclusion
- pediatric (age 24 months or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM).
Exclusion
- gestational age \< 33 weeks at birth
- gestational age \< 35 weeks on the day of surgery
- emergency surgery
- patient or parent history of coagulopathy/clotting abnormalities
- patient history of thrombophilia
- refusal to participate in the study,
- known severe allergic reaction/anaphylaxis to fibrinogen concentrate,
- administration of fibrinogen concentrate or cryoprecipitate in the 24 hours prior to surgery
- baseline fibrinogen level higher than 300 mg/dL (to avoid the risk of increasing the fibrinogen level above the normal upper level of 400 mg/dL)
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04376762
Start Date
October 26 2021
End Date
May 1 2023
Last Update
October 23 2023
Active Locations (1)
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1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908