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

NCT01475344 | Completed Phase 1 DMC

• 1 other identifier: FIinTIC
• Study Type: interventional
• Target: 67
• Locations: 3 countries
• Sites: 16

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

Conditions

Trauma; Massive Hemorrhage

Keywords

Trauma patient with major bleeding

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

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).

Drug: Human Fibrinogen Concentrate

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).

Drug: Placebo

Interventions

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).

Also known as: FGTW

Human Fibrinogen Concentrate

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).

Also known as: Placebo for Fibrinogen Concentrate

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (16)

Christophorus 1

Innsbruck, 6020, Austria

Location

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

Martin 2

Karres, 6462, Austria

Location

Christophorus 14

Niederöblarn, 8960, Austria

Location

AUVA Trauma Center

Salzburg, 5020, Austria

Location

Christophorus 6

Salzburg, 5020, Austria

Location

Alpin 2

Solden, 6450, Austria

Location

NEF Telfs

Telfs, 6410, Austria

Location

NAW Vöcklabruck

Vöcklabruck, 4840, Austria

Location

Regional Hospital Vöcklabruck

Vöcklabruck, 4840, Austria

Location

Christophorus 5

Zams, 6511, Austria

Location

Ambulace Car

Liberec, 46001, Czechia

Location

Krystof 18 Helicopter Base

Liberec, 46001, Czechia

Location

Hospital Liberec

Liberec, 46063, Czechia

Location

Christoph 3

Cologne, 50737, Germany

Location

Cologne-Merheim Medical Center

Cologne, 51109, Germany

Location

Related Publications (1)

• 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.

  PMID: 33109923 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Fibrinogen

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Dietmar Fries, Prof. MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating and Principal Investigator

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 21, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

AU (11); CZ (3); DE (2)