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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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).


Condition Intervention Phase
Trauma
Major Bleeding
Drug: Human Fibrinogen
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FGTW Drug: Human Fibrinogen
intravenous
Placebo Comparator: Placebo Drug: Placebo
intravenous

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475344

Contacts
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

Locations
Austria
Christophorus 12 Not yet recruiting
Feldkirchen, Austria, 8073
Contact: Thomas Raber, OA MD    +43316385 ext 81759    thomas.raber@medunigraz.at   
Principal Investigator: Thomas Raber, OA MD         
University Hospital Graz Not yet recruiting
Graz, Austria, 8036
Contact: Thomas Raber, OA MD    +316385 ext 81759    thomas.raber@medunigraz.at   
Principal Investigator: Thomas Raber, OA MD         
Christophorus 1 Recruiting
Innsbruck, Austria, 6020
Contact: Marc Kaufmann, MD    +43512504 ext 80471    marc.kaufmann@uki.at   
Principal Investigator: Marc Kaufmann, MD         
NEF Innsbruck Active, not recruiting
Innsbruck, Austria, 6020
Medical University Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Pamela Schech    +43512504 ext 80450    pamela.schech@i-med.ac.at   
Principal Investigator: Dietmar Fries, Prof. MD         
Martin 2 Recruiting
Karres, Austria, 6462
Contact: Christian Niederwanger, MD    +43512504 ext 82732    christian.niederwanger@uki.at   
Principal Investigator: Christian Niederwanger, MD         
Christophorus 4 Active, not recruiting
Kitzbühel, Austria, 6370
Christophorus 14 Recruiting
Niederöblarn, Austria, 8960
Contact: Christine Haas, MD    +436506344266    christine.haas@kages.at   
Principal Investigator: Christine Haas, MD         
University Hospital Salzburg (PMU)/Regional Hospital Salzburg Active, not recruiting
Salzburg, Austria, 5020
NEF Stadt Salzburg Active, not recruiting
Salzburg, Austria, 5020
AUVA Trauma Center Recruiting
Salzburg, Austria, 5020
Contact: Herbert Schöchl, MD    +436626580 ext 5877    herbert.schoechl@auva.at   
Principal Investigator: Herbert Schoechl, MD         
Christophorus 6 Recruiting
Salzburg, Austria, 5020
Contact: Bernhard Ziegler, OA MD    +436624482 ext 2701    b.ziegler@salk.at   
Principal Investigator: Bernhard Ziegler, OA MD         
NAW Vöcklabruck Active, not recruiting
Vöcklabruck, Austria, 4840
Regional Hospital Vöcklabruck Active, not recruiting
Vöcklabruck, Austria, 4840
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Dietmar Fries, Prof. MD Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Dietmar Fries, M.D., Coordinating and Principal Investigator, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01475344     History of Changes
Other Study ID Numbers: FIinTIC
Study First Received: October 27, 2011
Last Updated: November 21, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University Innsbruck:
Trauma patient with major bleeding

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014