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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dietmar Fries, M.D., Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01475344
First received: October 27, 2011
Last updated: December 7, 2015
Last verified: December 2015

October 27, 2011
December 7, 2015
September 2011
October 2015   (final data collection date for primary outcome measure)
Change of the Fibrinogen polymerisation measured with FIBTEM® MCF [ Time Frame: 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). ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01475344 on ClinicalTrials.gov Archive Site
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Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
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)

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Trauma
  • Massive Hemorrhage
  • 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 Name: FGTW
  • 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 Name: Placebo for Fibrinogen Concentrate
  • 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).

    Intervention: Drug: Human Fibrinogen Concentrate
  • 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).

    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
December 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Germany
 
NCT01475344
FIinTIC
Yes
Not Provided
Not Provided
Dietmar Fries, M.D., Medical University Innsbruck
Medical University Innsbruck
Not Provided
Principal Investigator: Dietmar Fries, Prof. MD Medical University Innsbruck
Medical University Innsbruck
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP