Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT01545635
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects =/\> 18 years and =/\< 80 years
2. Major trauma (ISS \> 15)
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
4. Presence of coagulopathy defined by ROTEM assays as follows,
* Patients with concomitant decreased fibrinogen polymerisation (ROTEM® FibTEM A10 of \< 7 mm after 10 min)
* Patients with concomitant decreased coagulation factor levels (ROTEM® ExTEM CT of \> 90 sec)
Exclusion Criteria:
1. Lethal injury
2. CPR on the scene,
3. Isolated brain injury, burn injury
4. Avalanche injury
5. Administration of FFP or coagulation factor concentrates before ED admission
6. Delayed (\> 6hours after trauma) admittance to ED
7. Known use of oral anticoagulants, or platelet aggregation inhibitors within 5 days before injury
8. Known history of severe allergic reaction to plasma products
9. Known history of congenital hemostasis disturbance, IgA or Protein C deficiency
10. Patients with a history of thromboembolic events or heparin induced thrombocytopenia (HIT) type 2 within the last year
11. Patients with a body weight \< 45kg and \> 150kg
12. Patients that are known to be pregnant
13. Jehova's Witness
14. Known participation in another clinical trial
15. Patient with known refusal of a participation in this clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01545635
Study Brief:
Protocol Section:
NCT01545635