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
  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, 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 Intervention Phase
Trauma
Massive Hemorrhage
Drug: Human Fibrinogen Concentrate
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).


Enrollment: 67
Study Start Date: September 2011
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo for Fibrinogen Concentrate

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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

Locations
Austria
Christophorus 1
Innsbruck, Austria, 6020
Medical University Innsbruck
Innsbruck, Austria, 6020
Martin 2
Karres, Austria, 6462
Christophorus 14
Niederöblarn, Austria, 8960
AUVA Trauma Center
Salzburg, Austria, 5020
Christophorus 6
Salzburg, Austria, 5020
Alpin 2
Sölden, Austria, 6450
NEF Telfs
Telfs, Austria, 6410
NAW Vöcklabruck
Vöcklabruck, Austria, 4840
Regional Hospital Vöcklabruck
Vöcklabruck, Austria, 4840
Christophorus 5
Zams, Austria, 6511
Czech Republic
Hospital Liberec
Liberec, Czech Republic, 46063
Krystof 18 Helicopter Base
Liberec, Czech Republic, 46001
Ambulace Car
Liberec, Czech Republic, 46001
Germany
Christoph 3
Cologne, Germany, 50737
Cologne-Merheim Medical Center
Cologne, Germany, 51109
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Principal Investigator: Dietmar Fries, Prof. MD Medical University Innsbruck
  More Information

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: December 7, 2015
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:
Hemorrhage
Wounds and Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2016