Clinical trial NCT01475344: Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
Official title: A Multicenter Double-blind, Placebo Controlled, Randomized, Pilot Trial to Assess the Efficacy of Pre-hospital Administration of Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Trauma
Massive Hemorrhage
Keywords: Trauma patient with major bleeding
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Trauma patient
2. Patient at the obvious age of equal or higher than 18 years of either sex
3. Major bleeding or occult bleeding with parameters of shock
4. Need for volume replacement therapy
5. Patient, who will be admitted to one of the participating hospitals

Exclusion Criteria:

1. Solely penetrating trauma
2. Solely head injury
3. In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor, volume)
4. Patient with inevitable lethal course as evaluated by emergency physician
5. Need for CPR on the scene
6. Deep hypothermia (below 30°C)
7. Obviously pregnant women
8. Patient with known recent history of thromboembolic events within the last 6 months
9. Patient known to be on anticoagulant therapy
10. Patient with known refusal of a participation in this clinical trial

Primary outcomes:
measure: Change of the Fibrinogen polymerisation measured with FIBTEM® MCF
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Christophorus 1
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Karres
country: Austria
facility: Martin 2
city: Niederöblarn
country: Austria
facility: Christophorus 14
city: Salzburg
country: Austria
facility: AUVA Trauma Center
city: Salzburg
country: Austria
facility: Christophorus 6
city: Sölden
country: Austria
facility: Alpin 2
city: Telfs
country: Austria
facility: NEF Telfs
city: Vöcklabruck
country: Austria
facility: NAW Vöcklabruck
city: Vöcklabruck
country: Austria
facility: Regional Hospital Vöcklabruck
city: Zams
country: Austria
facility: Christophorus 5
city: Liberec
country: Czech Republic
facility: Ambulace Car
city: Liberec
country: Czech Republic
facility: Krystof 18 Helicopter Base
city: Liberec
country: Czech Republic
facility: Hospital Liberec
city: Cologne
country: Germany
facility: Christoph 3
city: Cologne
country: Germany
facility: Cologne-Merheim Medical Center
Study officials:
affiliation: Medical University Innsbruck
name: Dietmar Fries, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.