Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients

Launched by UNIVERSITY OF VIRGINIA · May 1, 2020

Keywords

ClinConnect Summary

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; active control group) or
2. Fibrinogen Concentrate group (dose: 70 mg/kg; intervention group). There will be no placebo group since withholding treatment is neither consistent with standard of care nor acceptable ethically. No other aspects of care will be modified. In the event that an additional dose of fibrinogen supplementation is required (bleeding with documented hypofibrinogenemia) cryoprecip...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)