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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck

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