Safety Study of Nicardipine to Treat Cerebral Vasospasm

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Nicardipine

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