Human Fibrinogen Concentrate in Pediatric Cardiac Surgery

The goal of the study is to determine whether the use of Human Fibrinogen Concentrate
(RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and
infants undergoing cardiopulmonary bypass. RiaSTAP will be administered after termination of
Cardiopulmonary Bypass (CPB) at a dose of 70 mg/kg, in a prospective, randomized, controlled
study. We hypothesize that the administration of RiaSTAP in this manner will reduce
peri-operative bleeding and transfusion requirements.

Inclusion Criteria:

- Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus
Children's Hospital will be eligible for enrollment in the study.

Exclusion Criteria:

- Patients who fall outside of the age range for the study will be excluded. Patients
known to have had an anaphylactic or severe reaction to the drug or its components
will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM
MCF > 15mm, will be excluded.