Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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 (CPB)-associated bleeding in pediatric cardiac patients in whom
fibrinogen supplementation is indicated.
The investigators' hypothesis is that fibrinogen concentrate will be as effective as
cryoprecipitate in achieving adequate hemostasis after separation from CPB in pediatric
cardiac surgery patients.
Study Design: this will be a single-center, prospective, randomized, active-control study in
pediatric (24 months of age 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). Informed
consent will be obtained from a parent or a legal guardian prior to surgery and anesthesia.
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) cryoprecipitate will be administered to all study subjects
(including those who received FC).
The results of this study will be used for publication as well as the first stage towards a
significantly larger randomized multi-center trial (see below).
Based on the results of this pilot study the investigators plan to conduct a large
multi-center, randomized active-control non-inferiority trial in the future, comparing the
use of FC to cryoprecipitate in a much larger cohort of pediatric patients undergoing cardiac
surgery with CPB. Ultimately, the results of this trial are likely to improve the care of
pediatric cardiac surgical patients experiencing post-CPB bleeding, an under-studied yet
high-risk patient population.