Treatment of a blood-clotting disorder as a consequence of a major injury with fresh plasma or blood-clotting factor concentrats (RETIC)

Conditions: Major trauma (Injury Severity Score, ISS >15), clinical signs/risk of blood loss and coagulopathy as measured by rotational thrombelastometry (ROTEM)
MedDRA version: 14.0Level: LLTClassification code 10018988Term: Haemorrhage NOSSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Registration Number: EUCTR2011-004139-29-AT

Lead Sponsor: Medizinische Universität Innsbruck / UK für Anästhesie und Intensivmedizin & UK für Allgem. u. Chirurg. Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

I.1. Male and female subjects ? 18 years and < 80 years
I.2. Major trauma (ISS>15)
I.3. Clinical signs of ongoing bleeding or patients who are at risk for significant haemorrhage assessed and judged by the ED team in charge of patient
I.4. Presence of coagulopathy defined by ROTEM assays as follows,
o Patients with concomitant decreased fibrinogen polymerisation (ROTEM® FibTEM A10 of <7 mm after 10 min)
o Patients with concomitant decreased coagulation factor levels (ROTEM® ExTEM CT of >90 sec)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

E.1. Lethal injury
E.2. CPR on the scene,
E.3. Isolated brain injury, burn injury
E.4. Avalanche injury
E.5. Administration of FFP or coagulation factor concentrates before ED admission
E.6. Delayed (>6hours after trauma) admittance to ED
E.7. Known use of oral anticoagulants, or platelet aggregation inhibitors within 5 days before injury
E.8. Known history of severe allergic reaction to plasma products
E.9. Known history of congenital hemostasis disturbance, IgA or Protein C deficiency
E.10.Patients with a history of thromboembolic events or heparin induced thrombocytopenia (HIT) type 2 within the last year
E. 11. Patients with a body weight <45kg and >150kg
E.12. Patients that are known to be pregnant
E.13. Jehova‘s Witness
E.14. known participation in another clinical trial
E.15. Patient with known refusal of a participation in this clinical trial