67
Participants
Start Date
September 30, 2011
Primary Completion Date
October 31, 2015
Study Completion Date
December 31, 2015
Human Fibrinogen Concentrate
"intravenous infusion over 5 min/vial:~Body Weight: \< 30 kg / 30-60 kg / 60 - 90 kg / \> 90 kg~No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)~Fibrinogen Concentrate: 1.5 g / 3 g / 4.5 g / 6 g~Immediately after admission to hospital, the patient's parameters including blood collection (see below) will be measured for the second time (T2), if applicable, after the end of administration of the study drug. Additional measurements will be made 3 hours (T3), 9 hours (T4), and 24 hours (T5), 48 hours (T6) and one week after admission (T7). 30 days after inclusion in the study, a final investigation is planned (T8)."
Placebo
"intravenous infusion over 5 min/vial:~Body Weight: \< 30 kg / 30-60 kg / 60 - 90 kg / \> 90 kg~No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)~Placebo: 1.5 g / 3 g / 4.5 g / 6 g~Immediately after admission to hospital, the patient's parameters including blood collection (see below) will be measured for the second time (T2), if applicable, after the end of administration of the study drug. Additional measurements will be made 3 hours (T3), 9 hours (T4), and 24 hours (T5), 48 hours (T6) and one week after admission (T7). 30 days after inclusion in the study, a final investigation is planned (T8)."
NAW Vöcklabruck, Vöcklabruck
Regional Hospital Vöcklabruck, Vöcklabruck
AUVA Trauma Center, Salzburg
Christophorus 6, Salzburg
Christophorus 1, Innsbruck
Medical University Innsbruck, Innsbruck
NEF Telfs, Telfs
Alpin 2, Solden
Martin 2, Karres
Christophorus 5, Zams
Christophorus 14, Niederöblarn
Ambulace Car, Liberec
Krystof 18 Helicopter Base, Liberec
Hospital Liberec, Liberec
Christoph 3, Cologne
Cologne-Merheim Medical Center, Cologne
Medical University Innsbruck
OTHER