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

This study is currently recruiting participants.
Verified November 2012 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Dietmar Fries, M.D., Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01475344
First received: October 27, 2011
Last updated: November 21, 2012
Last verified: November 2012

October 27, 2011
November 21, 2012
September 2011
September 2013   (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
Not Provided
Not Provided
Not Provided
Not Provided
 
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, 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).

Not Provided
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
  • Major Bleeding
  • Drug: Human Fibrinogen
    intravenous
  • Drug: Placebo
    intravenous
  • Active Comparator: FGTW
    Intervention: Drug: Human Fibrinogen
  • Placebo Comparator: Placebo
    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.
 
Recruiting
60
Not Provided
September 2013   (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:

    • A01 Medical University Innsbruck
    • A02 Emergency Hospital Salzburg
    • A03 PMU Salzburg
    • A04 Regional Hospital Vöcklabruck
    • A05 Medical University Graz

Exclusion Criteria:

  1. Penetrating trauma
  2. Solely head injury
  3. In case of hemodynamic instability:

    Patient has to be excluded if the hemodynamic stabilisation (SBP below 90 mmHg and HR more than 100 per min) is not achieved after 15 minutes of resuscitation management in spite of volume therapy and administration of catecholamines

  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: Pamela Schech +43512504 ext 80450 pamela.schech@i-med.ac.at
Contact: Mirjam Bachler, MA. +43512504 ext 80451 mirjam.bachler@i-med.ac.at
Austria
 
NCT01475344
FIinTIC
Yes
Dietmar Fries, M.D., Medical University Innsbruck
Medical University Innsbruck
Not Provided
Principal Investigator: Dietmar Fries, Prof. MD Medical University Innsbruck
Medical University Innsbruck
November 2012

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