30
Participants
Start Date
October 26, 2021
Primary Completion Date
March 1, 2023
Study Completion Date
May 1, 2023
Fibrinogen
Fibrinogen Concentrate (Human) Injection \[Fibryga\] (dose: 70 mg/kg; intervention group). 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).
Cryoprecipitate
Cryoprecipitate group (dose: 10 ml/kg; active control group) 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).
University of Virginia Health System, Charlottesville
Collaborators (1)
Octapharma
INDUSTRY
University of Virginia
OTHER