Safety Study of Dantrolene in Subarachnoid Hemorrhage

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Subarachnoid Hemorrhage Cerebral Vasospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dantrolene

Dantrolene 1.25mg/kg IV every 6 hours x 7 days

Group Type EXPERIMENTAL

Dantrolene

Intervention Type DRUG

Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days

Placebo

Equiosmolar volume (5% Mannitol)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

equiosmolar volume (5% mannitol) every 6 hours x 7 days

Interventions

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Dantrolene

Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days

Intervention Type DRUG

Placebo

equiosmolar volume (5% mannitol) every 6 hours x 7 days

Intervention Type DRUG

Other Intervention Names

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Dantrium Free water/5% mannitol solution

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No