Safety Study of Dantrolene in Subarachnoid Hemorrhage

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01024972
First received: December 1, 2009
Last updated: February 18, 2015
Last verified: February 2015
Results First Received: January 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Subarachnoid Hemorrhage
Cerebral Vasospasm
Interventions: Drug: Dantrolene
Drug: Placebo

  Participant Flow
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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
  Description
Dantrolene

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

Placebo

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  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  16     15     31  
Age  
[units: years]
Mean (Standard Deviation)
  56  (12)     52  (11)     54  (12)  
Gender  
[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
  Show All 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
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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
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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
e-mail: susanne.muehlschlegel@umassmemorial.org


Publications of Results:
Other Publications:

Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01024972     History of Changes
Other Study ID Numbers: H-13441
Study First Received: December 1, 2009
Results First Received: January 2, 2015
Last Updated: February 18, 2015
Health Authority: United States: Institutional Review Board