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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01810302
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18 years of age and older
* Subarachnoid hemorrhage documented on head CT
* Fisher Grade 3 or 4
* Hunt Hess Grade 1-5
* Cerebral aneurysm as definitive source of subarachnoid hemorrhage
* Cerebral aneurysm must be treated via open or endovascular techniques
* Presence of external ventricular drain
* Written informed consent obtained from subject or subject's legally authorized representative
Exclusion Criteria:
* Absence or inability to have an external ventricular drain (coagulopathy)
* Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)
* Untreated cerebral aneurysm
* Inability to be randomized prior to post-hemorrhage day 4
* Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes
* Inability to administer study medication (severe intra-ventricular hemorrhage, occluded external ventricular drain)
* Inability to obtain angiography (coagulopathy, renal failure)
* Pregnant
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01810302
Study Brief:
Protocol Section:
NCT01810302