222
Participants
Start Date
April 3, 2018
Primary Completion Date
September 25, 2023
Study Completion Date
November 21, 2023
BT524
BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
FFP/Cryo
FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryoprecipitate, fixed dose of 10 units.
Site 02, Jette
Site 01, Leuven
Site 54, Brno
Site 51, Prague
Site 53, Prague
Site 52, Ústí nad Labem
Site 15, Bielefeld
Site 11, Bonn
Site 12, Hanover
Site 14, München
Site 13, Münster
Site 21, Warsaw
Site 31, Barcelona
Site 32, Barcelona
Site 33, Barcelona
Site34, Barcelona
Site 41, Liestal
Site 43, Zurich
Site 71, Basingstoke
Lead Sponsor
Collaborators (2)
PRA Health Sciences
INDUSTRY
ICON Clinical Research
INDUSTRY
Biotest
INDUSTRY