Safety Study of Dantrolene in Subarachnoid Hemorrhage

Completed

Phase 1/2 Results

Update History

10 Mar '15
The description was updated.
New
Once eligibility criteria are met, patients will be randomized to either dantrolene-IV or placebo (equiosmolar, volume-equivalent sterile water with 5% mannitol as dantrolene-IV also contains 5% mannitol). Study subjects will be visited daily by a study nurse to determine side effects, tolerability, record hemodynamic measures and laboratory values. Patients will have daily serum Na, osmolality, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALK) measured. In addition, daily bedside transcranial doppler will be performed by a blinded examiner. Patients will undergo cerebral angiograms per clinical routine. Angiographic measurements of arterial narrowing will be performed by a blinded radiologist. Specific stop criteria are pre-defined.
Old
Once eligibility criteria are met, patients will be randomized to either dantrolene-IV or placebo (equiosmolar, volume-equivalent sterile water with 5% mannitol as dantrolene-IV also contains 5% mannitol). Study subjects will be visited daily by a study nurse to determine side effects, tolerability, record hemodynamic measures and laboratory values. Patients will have daily serum Na, osmolality, AST, ALT and ALK measured. In addition, daily bedside transcranial doppler will be performed by a blinded examiner. Patients will undergo cerebral angiograms per clinical routine. Angiographic measurements of arterial narrowing will be performed by a blinded radiologist. Specific stop criteria are pre-defined.
The eligibility criteria were updated.
New
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)
Old
Inclusion Criteria: - Documented aneurysmal SAH by CTA, 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)
4 Dec '12
A location was updated in Worcester.
New
The overall status was removed for UMASS Medical School / UMass Memorial Medical Center.