Safety Study of Dantrolene in Subarachnoid Hemorrhage
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
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 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.