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

NCT ID: NCT01475344

Last Updated: 2015-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-12-31

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).

Conditions

Trauma; Massive Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Human Fibrinogen Concentrate

Intervention Type: 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).

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

FGTW; Placebo for Fibrinogen Concentrate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Dietmar Fries, M.D.

Coordinating and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dietmar Fries, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

Christophorus 1

Innsbruck, , Austria

Medical University Innsbruck

Innsbruck, , Austria

Martin 2

Karres, , Austria

Christophorus 14

Niederöblarn, , Austria

AUVA Trauma Center

Salzburg, , Austria

Christophorus 6

Salzburg, , Austria

Alpin 2

Solden, , Austria

NEF Telfs

Telfs, , Austria

NAW Vöcklabruck

Vöcklabruck, , Austria

Regional Hospital Vöcklabruck

Vöcklabruck, , Austria

Christophorus 5

Zams, , Austria

Ambulace Car

Liberec, , Czechia

Krystof 18 Helicopter Base

Liberec, , Czechia

Hospital Liberec

Liberec, , Czechia

Christoph 3

Cologne, , Germany

Cologne-Merheim Medical Center

Cologne, , Germany

Countries

Austria; Czechia; Germany

References

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.

Reference Type: DERIVED

PMID: 33109923 (View on PubMed)

Other Identifiers

FIinTIC

Identifier Type: -

Identifier Source: org_study_id