Safety Study of Dantrolene in Subarachnoid Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024972
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : March 5, 2015
Last Update Posted : March 5, 2015
American Heart Association
Information provided by (Responsible Party):
University of Massachusetts, Worcester

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Subarachnoid Hemorrhage
Cerebral Vasospasm
Interventions: Drug: Dantrolene
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients with aSAH were screened for eligibility between 10/2009 and 10/2012. Inclusion criteria were aSAH ≥18 years, aneurysm fully secured by coiling or clipping, Hunt&Hess grade <5, modified Fisher Scale >1, ALT, AST, AlkPhos <3x upper limit of normal, serum Na (sNa) ≥135mmol/L and no mannitol or hypertonic saline prior to drug infusion.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Routine patient management: All aSAH patients were treated according to our institutional protocol following published aSAH critical care guidelines, including admission to our closed neuroscience intensive care unit (neuroICU) with board-certified neurointensivist as the primary attending.

Reporting Groups

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

Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days


Equiosmolar volume (5% Mannitol)

Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days

Participant Flow:   Overall Study
    Dantrolene   Placebo
STARTED   16   15 
COMPLETED   16   15 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Dantrolene Intravenous Datrolene 1.25 mg/kg (includes 5% mannitol) every 6 hours for seven days.
Placebo Equiosmolar volume (5% mannitol) every 6 hours for seven days.
Total Total of all reporting groups

Baseline Measures
   Dantrolene   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   15   31 
[Units: Years]
Mean (Standard Deviation)
 56  (12)   52  (11)   54  (12) 
[Units: Participants]
Female   14   12   26 
Male   2   3   5 
Race/Ethnicity, Customized 
[Units: Participants]
White   15   9   24 
Hispanic/Latino   0   6   6 
African American   1   0   1 

  Outcome Measures

1.  Primary:   Hyponatremia   [ Time Frame: Seven days ]

2.  Secondary:   Liver Toxicity   [ Time Frame: 7 days ]

3.  Secondary:   In-hospital Mortality   [ Time Frame: up to 90 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Placebo group consisted of free water with 5% mannitol to achieve the same equiosmolar solution as IV-D which requires reconstitution in free water. Unable to differentiate whether hyponatremia or brain oedema was due to IV-D or its solution.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Susanne Muehlschlegel
Organization: University of Massachusetts Medical School
phone: 508-421-5500

Publications of Results:
Other Publications:

Responsible Party: University of Massachusetts, Worcester Identifier: NCT01024972     History of Changes
Other Study ID Numbers: H-13441
First Submitted: December 1, 2009
First Posted: December 3, 2009
Results First Submitted: January 2, 2015
Results First Posted: March 5, 2015
Last Update Posted: March 5, 2015