Safety Study of Nicardipine to Treat Cerebral Vasospasm

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cerebral Vasospasm

In brief

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

Key facts

Study ID

NCT01810302

Run by

University of Florida

People needed

2

Starts

2013-08-01

Expected to finish

2014-01-01

Last updated by the study team

2014-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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