Status:
TERMINATED
Safety Study of Nicardipine to Treat Cerebral Vasospasm
Lead Sponsor:
University of Florida
Conditions:
Cerebral Vasospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.
Detailed Description
Subarachnoid hemorrhage accounts for approximately 5% of all strokes and affects 30,000 Americans per year. Poor outcome from aneurysmal subarachnoid hemorrhage (SAH) occurs in 50 to 75% of patients, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01810302
Start Date
August 1 2013
End Date
January 1 2014
Last Update
August 29 2014
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610