Status:
COMPLETED
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
Lead Sponsor:
Medical University Innsbruck
Conditions:
Trauma
Massive Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 wi...
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 wi...
Eligibility Criteria
Inclusion
- Trauma patient
- Patient at the obvious age of equal or higher than 18 years of either sex
- Major bleeding or occult bleeding with parameters of shock
- Need for volume replacement therapy
- Patient, who will be admitted to one of the participating hospitals
Exclusion
- Solely penetrating trauma
- Solely head injury
- In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor, volume)
- Patient with inevitable lethal course as evaluated by emergency physician
- Need for CPR on the scene
- Deep hypothermia (below 30°C)
- Obviously pregnant women
- Patient with known recent history of thromboembolic events within the last 6 months
- Patient known to be on anticoagulant therapy
- Patient with known refusal of a participation in this clinical trial
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01475344
Start Date
September 1 2011
End Date
December 1 2015
Last Update
December 8 2015
Active Locations (16)
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1
Christophorus 1
Innsbruck, Austria, 6020
2
Medical University Innsbruck
Innsbruck, Austria, 6020
3
Martin 2
Karres, Austria, 6462
4
Christophorus 14
Niederöblarn, Austria, 8960