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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01414894
Eligibility Criteria:
Inclusion Criteria:
1. Age more than or equal to 18 years
2. Aneurysmal SAH of any clinical grade
3. Head computed tomography demonstrating SAH
4. Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH
5. Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding
6. Signed consent by study participant or applicable legal representative within 72 hours after SAH
Exclusion Criteria:
1. History of traumatic SAH
2. Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
3. Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
4. Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding
5. Time of symptom onset cannot be reliably determined
6. Intracranial hypertension (ICP \>25 mm Hg) at the time of screening
7. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D)
8. Acute, evolving or recent myocardial infarction
9. Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability
10. Chronic renal failure requiring dialysis
11. Suspected or confirmed pregnancy
12. Non English speaking
13. A condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation
14. Severe terminal disease with life expectancy less than 6 months
15. Refusal of consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01414894
Study Brief:
Protocol Section:
NCT01414894