Status:
COMPLETED
Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Cerebral Vasospasm After Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Subarachnoid hemorrhage (SAH) is a devastating acute brain injury due to bleeding onto the brain surface from a ruptured aneurysm. Cerebral vasospasm (cVSP; critical narrowing of brain arteries) is a ...
Detailed Description
Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of dantrolene, by determining the treatment related adverse events, in participants with cVSP after SAH; and 2) to ...
Eligibility Criteria
Inclusion
- Participants with aneurysmal SAH admitted to the Massachusetts General Hospital NeuroICU (Blake 12) and undergoing standard-of-care daily transcranial doppler (TCD).
- Participants with unilateral or bilateral anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA), or basilar artery vasospasm as defined by the following TCD criteria
- a \>50% mean velocity increase from the baseline mean TCD velocity (baseline is the first TCD measurement, usually within 24hrs of admission), or
- peak systolic TCD velocities of 200 cm/s or higher in the MCA or ACA (for MCA with a concurrent ipsilateral LR of 3.0 or higher), or peak systolic TCD velocities of 120 cm/s or higher in the PCA or basilar artery, or
- any daily 100 cm/s peak systolic TCD velocity increase from the previous day, or
- any longitudinal mean TCD velocity increase of 80 cm/s or more
Exclusion
- Inability to obtain consent from patient or health care proxy
- Age \< 18 years
- Pregnancy
- Traumatic SAH
- Known allergy to dantrolene
- Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT \>165 Units/L, AST \>120 Units/L, alkaline phosphatase \>345 Units/L (three times upper limit of normal)
- Participants on verapamil
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00964548
Start Date
July 1 2007
End Date
October 1 2009
Last Update
May 25 2012
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
UMASS Memorial Medical Center/UMASS Medical School
Worcester, Massachusetts, United States, 01655