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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05449834
Eligibility Criteria:
Inclusion Criteria:
1. Adult affected by trauma (≥18yrs)
2. Judged to have active haemorrhage by treating clinician
3. Activation of local MHP and/or Transfusion of Emergency Blood Products
4. FIBTEM A5 ≤ 10mm or TEG FF A5 ≤ 15mm or FibC ≤ 2 g/l
Exclusion Criteria:
1. Injury judged incompatible with survival
2. Randomisation unable to occur within 6 hours of presentation to hospital
3. Known pregnancy
4. Known genetic or drug induced coagulation disorder
5. Known objection to blood products
6. Dedicated prior fibrinogen replacement
7. Participation in a competing study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05449834
Study Brief:
Protocol Section:
NCT05449834