Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

October 31, 2015

Study Completion Date

December 31, 2015

Conditions
TraumaMassive Hemorrhage
Interventions
DRUG

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)."

DRUG

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)."

Trial Locations (16)

4840

NAW Vöcklabruck, Vöcklabruck

Regional Hospital Vöcklabruck, Vöcklabruck

5020

AUVA Trauma Center, Salzburg

Christophorus 6, Salzburg

6020

Christophorus 1, Innsbruck

Medical University Innsbruck, Innsbruck

6410

NEF Telfs, Telfs

6450

Alpin 2, Solden

6462

Martin 2, Karres

6511

Christophorus 5, Zams

8960

Christophorus 14, Niederöblarn

46001

Ambulace Car, Liberec

Krystof 18 Helicopter Base, Liberec

46063

Hospital Liberec, Liberec

50737

Christoph 3, Cologne

51109

Cologne-Merheim Medical Center, Cologne

All Listed Sponsors
lead

Medical University Innsbruck

OTHER

NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) | Biotech Hunter | Biotech Hunter