Subarachnoid Hemorrhage Clinical Trial
Official title:
Dantrolene in the Prevention and Treatment of Cerebral Vasospasm in Subarachnoid Hemorrhage
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 known complication after SAH and significantly increases disability and
death after SAH. Vasospasm is difficult to treat and can lead to stroke. Animal studies have
shown that the muscles in the artery wall play a role in cVSP.
Dantrolene has been FDA approved and extensively used in clinical practice as a muscle
relaxant for more than 30 years. It has been shown to provide some benefit in animal studies
of cVSP, as well as in a small number of humans. However, the first human studies have only
been observational and over a short period of time.
This study will evaluate the safety and tolerability of intravenous dantrolene given every 6
hours over seven days to patients with or at risk for cVSP after SAH. The goal is to
determine if future efficacy studies should be done to determine if treatment with
Dantrolene may improve the outcome of patients with cVSP after SAH.
Status | Completed |
Enrollment | 31 |
Est. completion date | October 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented aneurysmal SAH by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or angiography - Secured aneurysm (coiled or clipped) - Enrollment achievable within 14 days after SAH Exclusion Criteria: - Pregnancy - Prior history of cirrhosis or hepatitis B/C, or any two of the following three liver enzymes elevated to greater than: ALT >120 Units/L, AST >120 Units/L, alkaline phosphatase >345 Units/L (three times upper limit of normal) - Patients on verapamil - Patients with brain edema and/or elevated intracranial pressure (>25mm Hg) - Patients treated with hypertonic saline or mannitol prior to enrollment - Patients with too severe SAH with low likelihood of survival (Hunt & Hess 5) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UMASS Medical School / UMass Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | American Heart Association |
United States,
Muehlschlegel S, Carandang R, Hall W, Kini N, Izzy S, Garland B, Ouillette C, van der Bom IM, Flood TF, Gounis MJ, Weaver JP, Barton B, Wakhloo AK. Dantrolene for cerebral vasospasm after subarachnoid haemorrhage: a randomised double blind placebo-control — View Citation
Muehlschlegel S, Rordorf G, Bodock M, Sims JR. Dantrolene mediates vasorelaxation in cerebral vasoconstriction: a case series. Neurocrit Care. 2009;10(1):116-21. doi: 10.1007/s12028-008-9132-5. Epub 2008 Aug 12. — View Citation
Muehlschlegel S, Rordorf G, Sims J. Effects of a single dose of dantrolene in patients with cerebral vasospasm after subarachnoid hemorrhage: a prospective pilot study. Stroke. 2011 May;42(5):1301-6. doi: 10.1161/STROKEAHA.110.603159. Epub 2011 Mar 31. — View Citation
Muehlschlegel S, Sims JR. Dantrolene: mechanisms of neuroprotection and possible clinical applications in the neurointensive care unit. Neurocrit Care. 2009;10(1):103-15. doi: 10.1007/s12028-008-9133-4. Epub 2008 Aug 12. Review. — View Citation
Salomone S, Soydan G, Moskowitz MA, Sims JR. Inhibition of cerebral vasoconstriction by dantrolene and nimodipine. Neurocrit Care. 2009;10(1):93-102. doi: 10.1007/s12028-008-9153-0. Epub 2008 Oct 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hyponatremia | Number of subjects who developed hyponatremia (sNa =132mmol/L) | Seven days | Yes |
Secondary | Liver Toxicity | Number of subjects who developed liver toxicity as evidenced by Liver Function Test elevation greater than 5 times the upper limit of normal. | 7 days | Yes |
Secondary | In-hospital Mortality | Number of subjects who expired during hospitalization. | up to 90 days | No |
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