Examination of Intracarotid ProliNO in Cerebral Vasospasm
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Status:
Trial halted. No results available.
Purpose:
To study the effects of ProliNO on brain artery spasms in humans caused by bleeding from a ruptured brain aneurysm.
Interventions:
proline nitric oxide
PROLI/NO (also "PROLINO" or "ProliNO") is the abbreviation of proline nitric oxide or proline NO. It is also referred to as a nitric oxide donor. It is an experimental drug, whose effects on vasospasms (or strokes) are being tested. It is a calcium inhibitor.
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Location(s):
INOVA Fairfax Hospital, Falls Church, Va.
Year Started:
2003
Design:
Nonrandomized clinical trial.
Inclusion Criteria
Patients diagnosed with arteriographically demonstrated vasospasm.
Exclusion Criteria
Patients hemodynamically instable, with acute infection, renal disorders, cardiac arrhythmias, pulmonary edema, hyponatremia if Na+ less than 115 mRg/L.
Patient Involvement:
Patients will undergo a neurological assessment and physical exam to evalute the patient's ability to tolerate the procedure, blood tests before and after procedure and cerebral arteriogram. The procedure will involve sedation, and 4 increasing doses of ProliNO injected into the vessel via catheter.
Primary Outcome:
Opening of vessel exhibiting evidence of spasms.
Results:
Have been unable to get current results as of 2/21/08-jh.
Source of Information:
NIH website
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Web Links and Publications:
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This information last updated on: 12/10/2008
Reviewed on: 12/10/2008.
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