Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02822599
Study type Interventional
Source Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Contact
Status Completed
Phase Phase 4
Start date June 1, 2017
Completion date December 24, 2020

See also
  Status Clinical Trial Phase
Withdrawn NCT00916656 - Fibrinogen Concentrate (Human) - Efficacy and Safety Study Phase 3
Completed NCT05780125 - Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness Phase 2
Recruiting NCT03884725 - Fibrinogen Concentrate In Children Cardiac Surgery 2 Phase 4
Recruiting NCT05634005 - Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence N/A
Withdrawn NCT04636268 - FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis Phase 3
Recruiting NCT05711524 - Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding Phase 4