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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT05889650
Eligibility Criteria:
Inclusion Criteria:
1. 18-65 years age
2. Glasgow Coma Scale (GCS) 3-8
3. Pupils symmetric and bilaterally reactive
4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT
5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
6. First randomization and intervention may be commenced within 24 hours of injury
7. ELD safety score ≥5
Exclusion Criteria:
1. GCS \>8
2. Cisterns on CT completely effaced
3. Midline shift on CT \>5mm
4. GCS 3 with dilated and fixed pupils
5. Uncal or tonsillar herniation on admission or post-operative brain CT
6. Temporal lobe contusions
7. Penetrating TBI
8. Primary hemicraniectomy
9. Pregnancy
10. Prisoners
11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year
13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05889650
Study Brief:
Protocol Section:
NCT05889650