Clincosm LogoSign in Get a demo

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

Sponsor
Medical University Innsbruck (Other)
Overall Status
Completed
CT.gov ID
NCT01475344
Collaborator
(none)
67
Enrollment
16
Locations
2
Arms
51
Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Human Fibrinogen Concentrate
  • Drug: Placebo
 Phase 1/Phase 2

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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).

Drug: 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).
Other Names:
  • FGTW

    		•
    Placebo Comparator: 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).

    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).
    Other Names:
  • Placebo for Fibrinogen Concentrate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Christophorus 1 Innsbruck Austria 6020
    2 Medical University Innsbruck Innsbruck Austria 6020
    3 Martin 2 Karres Austria 6462
    4 Christophorus 14 Niederöblarn Austria 8960
    5 AUVA Trauma Center Salzburg Austria 5020
    6 Christophorus 6 Salzburg Austria 5020
    7 Alpin 2 Sölden Austria 6450
    8 NEF Telfs Telfs Austria 6410
    9 NAW Vöcklabruck Vöcklabruck Austria 4840
    10 Regional Hospital Vöcklabruck Vöcklabruck Austria 4840
    11 Christophorus 5 Zams Austria 6511
    12 Ambulace Car Liberec Czech Republic 46001
    13 Krystof 18 Helicopter Base Liberec Czech Republic 46001
    14 Hospital Liberec Liberec Czech Republic 46063
    15 Christoph 3 Cologne Germany 50737
    16 Cologne-Merheim Medical Center Cologne Germany 51109

    Sponsors and Collaborators

    • Medical University Innsbruck

    Investigators

    • Principal Investigator: Dietmar Fries, Prof. MD, Medical University Innsbruck

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dietmar Fries, M.D., Coordinating and Principal Investigator, Medical University Innsbruck
    ClinicalTrials.gov Identifier:
    NCT01475344
    Other Study ID Numbers:
    • FIinTIC
    First Posted:
    Nov 21, 2011
    Last Update Posted:
    Dec 8, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Dietmar Fries, M.D., Coordinating and Principal Investigator, Medical University Innsbruck
    Trauma patient with major bleeding
    Additional relevant MeSH terms:
    Hemorrhage
    Wounds and Injuries

    Study Results

    No Results Posted as of Dec 8, 2015