Trauma Clinical Trial
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)
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
Status | Completed |
Enrollment | 67 |
Est. completion date | December 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Christophorus 1 | Innsbruck | |
Austria | Medical University Innsbruck | Innsbruck | |
Austria | Martin 2 | Karres | |
Austria | Christophorus 14 | Niederöblarn | |
Austria | AUVA Trauma Center | Salzburg | |
Austria | Christophorus 6 | Salzburg | |
Austria | Alpin 2 | Sölden | |
Austria | NEF Telfs | Telfs | |
Austria | NAW Vöcklabruck | Vöcklabruck | |
Austria | Regional Hospital Vöcklabruck | Vöcklabruck | |
Austria | Christophorus 5 | Zams | |
Czech Republic | Ambulace Car | Liberec | |
Czech Republic | Hospital Liberec | Liberec | |
Czech Republic | Krystof 18 Helicopter Base | Liberec | |
Germany | Christoph 3 | Cologne | |
Germany | Cologne-Merheim Medical Center | Cologne |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria, Czech Republic, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the Fibrinogen polymerisation measured with FIBTEM® MCF | 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). | 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). | No |
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