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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT02100592
Eligibility Criteria:
Inclusion Criteria:
1. Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
2. Age between 18 and 75 years
3. Glasgow Coma Scale ≤ 8 at entrance in ICUs
4. Adequate respiratory exchange with PaO2/FiO2 ≥ 250
5. Absence of sedation increased
Exclusion Criteria:
1. Major chest trauma with multiple rib fractures and / or pneumothorax
2. Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
3. Cardiovascular instability despite support with amines
4. Intracranial pressure (ICP)\> 25 mm / Hg
5. Cerebral Perfusion Pressure (PPC) \<60 mm / Hg
6. Severe kidney failure requiring replacement therapy
7. Decompensated liver disease
8. Hematocrit value of ≤ 30%
9. Body weight\> 135 kg or height\> 210 cm
10. Deep vein thrombosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02100592
Study Brief:
Protocol Section:
NCT02100592