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The Role of Human Fibrinogen Concentrate (RiaSTAP) in Decreasing Blood Loss and the Need for Component Blood Therapy in Infants Undergoing Cardiopulmonary Bypass.
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.
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.
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
No
Nickalus Children's Hospital f/k/a Miami Children's Hospital
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Start Date
June 1, 2017
Primary Completion Date
August 26, 2019
Completion Date
December 24, 2020
Last Updated
September 16, 2021
30
ACTUAL participants
RiaStAP
DRUG
Saline
DRUG
Lead Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
NCT04676880
NCT07411079
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