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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Fibrinogen Concentrate | Active Comparator | 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 Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Fibrinogen Concentrate | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Fibrinogen polymerisation measured with FIBTEM® MCF | 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dietmar Fries, Prof. MD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christophorus 1 | Innsbruck | 6020 | Austria | |||
| Medical University Innsbruck |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33109923 | Derived | Ziegler B, Bachler M, Haberfellner H, Niederwanger C, Innerhofer P, Hell T, Kaufmann M, Maegele M, Martinowitz U, Nebl C, Oswald E, Schochl H, Schenk B, Thaler M, Treichl B, Voelckel W, Zykova I, Wimmer C, Fries D; FIinTIC study group. Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study. Eur J Anaesthesiol. 2021 Apr 1;38(4):348-357. doi: 10.1097/EJA.0000000000001366. |
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| Placebo | Drug | 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). |
|
|
| Innsbruck |
| 6020 |
| Austria |
| Martin 2 | Karres | 6462 | Austria |
| Christophorus 14 | Niederöblarn | 8960 | Austria |
| AUVA Trauma Center | Salzburg | 5020 | Austria |
| Christophorus 6 | Salzburg | 5020 | Austria |
| Alpin 2 | Solden | 6450 | Austria |
| NEF Telfs | Telfs | 6410 | Austria |
| NAW Vöcklabruck | Vöcklabruck | 4840 | Austria |
| Regional Hospital Vöcklabruck | Vöcklabruck | 4840 | Austria |
| Christophorus 5 | Zams | 6511 | Austria |
| Ambulace Car | Liberec | 46001 | Czechia |
| Krystof 18 Helicopter Base | Liberec | 46001 | Czechia |
| Hospital Liberec | Liberec | 46063 | Czechia |
| Christoph 3 | Cologne | 50737 | Germany |
| Cologne-Merheim Medical Center | Cologne | 51109 | Germany |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001779 | Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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