Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
Trauma, Massive Hemorrhage
About this trial
This is an interventional treatment trial for Trauma focused on measuring Trauma patient with major bleeding
Eligibility Criteria
Inclusion Criteria:
- Trauma patient
- Patient at the obvious age of equal or higher than 18 years of either sex
- Major bleeding or occult bleeding with parameters of shock
- Need for volume replacement therapy
- Patient, who will be admitted to one of the participating hospitals
Exclusion Criteria:
- Solely penetrating trauma
- Solely head injury
- In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor, volume)
- Patient with inevitable lethal course as evaluated by emergency physician
- Need for CPR on the scene
- Deep hypothermia (below 30°C)
- Obviously pregnant women
- Patient with known recent history of thromboembolic events within the last 6 months
- Patient known to be on anticoagulant therapy
- Patient with known refusal of a participation in this clinical trial
Sites / Locations
- Christophorus 1
- Medical University Innsbruck
- Martin 2
- Christophorus 14
- AUVA Trauma Center
- Christophorus 6
- Alpin 2
- NEF Telfs
- NAW Vöcklabruck
- Regional Hospital Vöcklabruck
- Christophorus 5
- Ambulace Car
- Krystof 18 Helicopter Base
- Hospital Liberec
- Christoph 3
- Cologne-Merheim Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Human Fibrinogen Concentrate
Placebo
Fibrinogen Concentrate will be administrated 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: 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 administrated 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).