Clinical Trial: Human Fibrinogen Concentrate in Pediatric Cardiac Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Role of Human Fibrinogen Concentrate (RiaSTAP) in Decreasing the Need for Component Blood Therapy in Infants Undergoing Cardiopulmonary Bypass.

Brief Summary: The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.

Detailed Summary: The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease 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.
Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Current Primary Outcome: Patients suffering from postoperative bleeding after surgery [ Time Frame: 24 hours after surgery ]

Primary efficacy endpoint to measure bleeding cc/kg, identity and total volume of transfused blood products


Original Primary Outcome: Same as current

Current Secondary Outcome: Post-Op End Points - Adverse Events [ Time Frame: 24 hours after surgery ]

Patients requiring ventilator support, LOS in the CICU, re-exploration for bleeding, LOS in the hospital, monitoring of adverse events


Original Secondary Outcome: Same as current

Information By: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Dates:
Date Received: June 30, 2016
Date Started: January 2017
Date Completion: April 2019
Last Updated: April 5, 2017
Last Verified: April 2017