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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT02187120
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (estimated age 18 years or older)
* Injured through any mechanism
* Coagulopathy of severe trauma (COAST) score of 3 points or greater
* First dose of study drug can be administered within three hours of injury
* Patients to be transported to a participating trauma centre
COAST score
* Entrapment (ie in vehicle) \[Yes = 1, No = 0\]
* Systolic blood pressure \[\<90 mmHg = 2, \<100 mmHg = 1, ≥100 mmHg = 0\]
* Temperature \[\<32℃ =2, \<35℃ = 1, ≥35℃ = 0\]
* Major chest injury likely to require intervention (e.g. decompression, chest tube) \[Yes = 1, No = 0\]
* Likely intra-abdominal or pelvic injury \[Yes = 1, No = 0\]
Exclusion Criteria:
* Suspected pregnancy
* Nursing home residents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02187120
Study Brief:
Protocol Section:
NCT02187120