Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
- Conditions
- Massive HemorrhageTrauma
- Interventions
- Drug: Placebo
- Registration Number
- NCT01475344
- Lead Sponsor
- Medical University Innsbruck
- Brief Summary
Severe traumatized patients with visible significant bleeding and/or with clinical signs of internal significant bleeding treated by an emergency doctor of the helicopter service or the ground team will be enrolled in the study (inclusion- and exclusion criteria: see above). If a patient meets the inclusion criteria and is recruited for the study, FGTW or 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)
Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g
- Detailed Description
Severe traumatized patients with visible significant bleeding and/or with clinical signs of internal significant bleeding treated by an emergency doctor of the helicopter service or the ground team will be enrolled in the study (inclusion- and exclusion criteria: see above). If a patient meets the inclusion criteria and is recruited for the study, his baseline values on the scene (T1) will first be collected including the first blood collection as well as documentation of the clinical parameters (hemodynamics, respiratory and neurological function, etc.). Subsequently, 30 patients will be randomized to receive about 50 mg/kg BW fibrinogen concentrate (one vial for each 30 kg body weight, estimated by the emergency physician), while the other 30 patients receive placebo (also one vial including 100 ml for each 30 kg body weight). The flow rate should not exceed 100 ml within 5 minutes.
FGTW or 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)
Fibrinogen (if applicable): 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).
Coagulation management after admission to hospital is depending on the specific demands of the patient and should be performed according to the recommendations of the Austrian Society for Anaesthesiology, Intensive Care Medicine and Resuscitation (ÖGARI) (http://www.oegari.at/web_files/dateiarchiv/116/key%20messages%20management%20of%20TIC%202011.pdf). Blood loss, transfusion requirements, volume therapy and coagulation therapy will be documented.
When the bleeding is under control thromboprophylaxis has to be performed according to the international standard of care earliest after 24 hours after cessation of bleeding (preferably using enoxaparin).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Human Fibrinogen Concentrate Human Fibrinogen Concentrate 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 Placebo 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).
- Primary Outcome Measures
Name Time Method Change of the Fibrinogen polymerisation measured with FIBTEM® MCF The average period for the measurement (MCF) of the primary outcome is 60 minutes . Timepoints of measurements: Emergency scene (minute 0) and arrival to the hospital (on average after 60 minutes). Further measurements and investigations will be done until 7 days after the hospital admission. The patient will be followed up until 30 days (final interview).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Medical University Innsbruck
🇦🇹Innsbruck, Austria
NAW Vöcklabruck
🇦🇹Vöcklabruck, Austria
Christophorus 14
🇦🇹Niederöblarn, Austria
NEF Telfs
🇦🇹Telfs, Austria
Christophorus 6
🇦🇹Salzburg, Austria
Christophorus 5
🇦🇹Zams, Austria
Christophorus 1
🇦🇹Innsbruck, Austria
Krystof 18 Helicopter Base
🇨🇿Liberec, Czech Republic
Ambulace Car
🇨🇿Liberec, Czech Republic
Hospital Liberec
🇨🇿Liberec, Czech Republic
Martin 2
🇦🇹Karres, Austria
Cologne-Merheim Medical Center
🇩🇪Cologne, Germany
AUVA Trauma Center
🇦🇹Salzburg, Austria
Regional Hospital Vöcklabruck
🇦🇹Vöcklabruck, Austria
Alpin 2
🇦🇹Sölden, Austria
Christoph 3
🇩🇪Cologne, Germany