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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT03201094
Eligibility Criteria:
Inclusion criteria:
1. . Being diagnosed with aneurysmal SAH
2. . Aneurysmal repair within 48 hours of ictus.
3. . Age between 25 and 80 years old. (\>=25 years old and \<=80 years old)
4. . Expected stay in the NCCU \> 72 hours.
5. . Admission Hunt Hess Grade \>=2.
6. modified Fisher score \>1.
Exclusion criteria:
1. . Subjects diagnosed with SAH from trauma, rupture of an arteriovenous malformation, neoplasm, vasculitis, or other secondary causes;
2. . Unlikely to survive one week post hemorrhage either due to impending brain death or likely request for withdrawal of care;
3. . Unlikely to remain in the ICU for more than 7 days;
4. . Body mass index \< 15 or \>40 kg/m2;
5. . Allergy to whey protein;
6. . Evidence of lower extremity paresis or spasticity within 48 hours of injury
7. . Pre-morbid modified Rankin Score \>1.
8. . Known pregnancy
9. . Presence of active malignancy
10. . Diagnosis of an inflammatory disorder
11. . Presence of a neuromuscular disorder
12. . Diagnosis of chronic renal insufficiency or acute kidney injury (GFR \< 30 mL/min/1.73m2)
13. . Hepatic insufficiency defined as AST/ALT levels \>2.5 above normal upper limits.
14. . On-going seizure activity as assessed clinically or by electrographic detection on continuous electroencephalogram (cEEG) at time of enrollment
15. . Prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03201094
Study Brief:
Protocol Section:
NCT03201094