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Trial record 92 of 195 for:    Hemorrhage AND SAH

Safety Study of Dantrolene to Treat Cerebral Vasospasm After 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.
ClinicalTrials.gov Identifier: NCT00964548
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Susanne Muehlschlegel, University of Massachusetts, Worcester

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cerebral Vasospasm After Subarachnoid Hemorrhage
Intervention Drug: Dantrolene
Enrollment 10
Recruitment Details Recruitment dates: June 2007 - October 2008 Massachusetts General Hospital NeuroICU
Pre-assignment Details Participants were excluded from study if transcranial doppler (TCDs) did not show elevated velocities suggesting vasospasm. See inclusion criteria regarding specifics. After enrollment, TCDs were repeated. Once the repeat TCD confirmed elevated velocities suggestive of vasospasm, a single dose of IV dantrolene was infused.
Arm/Group Title Dantrolene (Low Dose) Dantrolene (High Dose)
Hide Arm/Group Description Single dose of Dantrolene 1.25 mg/kg infused over 60 min. Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Dantrolene (Low Dose) Dantrolene (High Dose) Total
Hide Arm/Group Description Single dose of Dantrolene 1.25 mg/kg infused over 60 min. Single dose of Dantrolene 2.5 mg/kg infused over 60 min. Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
42  (9) 44  (10) 43  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
3
  60.0%
2
  40.0%
5
  50.0%
Male
2
  40.0%
3
  60.0%
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion)
Hide Description Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).
Time Frame baseline until 135 minutes post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dantrolene (Low Dose) Dantrolene (High Dose)
Hide Arm/Group Description:
Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Overall Number of Participants Analyzed 5 5
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-8
(-26 to 10)
-3.4
(-19 to 12)
2.Secondary Outcome
Title Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)
Hide Description Peak Systolic Velocity of vessel in vasospasm (Change from baseline peak systolic velocity (pre-infusion) over time until 135 minutes post-infusion).
Time Frame baseline until 135 minutes post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dantrolene (Low Dose) Dantrolene (High Dose)
Hide Arm/Group Description:
Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Overall Number of Participants Analyzed 5 5
Mean (95% Confidence Interval)
Unit of Measure: cm/s
-30
(-47 to 12)
-26
(-56 to 8)
3.Secondary Outcome
Title Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)
Hide Description Mean flow velocities of vessel in vasospasm (Change from baseline mean flow velocity (pre-infusion) over time until 135 minutes post-infusion).
Time Frame baseline until 135 minutes post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dantrolene (Low Dose) Dantrolene (High Dose)
Hide Arm/Group Description:
Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
Overall Number of Participants Analyzed 5 5
Mean (95% Confidence Interval)
Unit of Measure: cm/s
-18
(-32 to -3)
-13
(-34 to 8)
Time Frame Up to 24 hours after Dantrolene infusion
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dantrolene (Low Dose) Dantrolene (High Dose)
Hide Arm/Group Description Single dose of Dantrolene 1.25 mg/kg infused over 60 min. Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
All-Cause Mortality
Dantrolene (Low Dose) Dantrolene (High Dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dantrolene (Low Dose) Dantrolene (High Dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/5 (0.00%)    
Vascular disorders     
Hypotension  [1]  1/5 (20.00%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Hypotension during infusion due to vasopressor infusion stop (ran out during infusion, leading to BP drop).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dantrolene (Low Dose) Dantrolene (High Dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Vascular disorders     
Venous Irritation   0/5 (0.00%)  0 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Limitations of this trial include the small n. No power analysis was performed, but rather a convenience sample was chosen as this was a proof-of-concept study. Transcranial Doppler measurements are operator dependent.
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: Susanne Muehlschlegel, MD, MPH, Principal Investigator
Organization: UMASS Medical School
Phone: 508-856-4667
Responsible Party: Susanne Muehlschlegel, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00964548     History of Changes
Other Study ID Numbers: H-13076
First Submitted: August 23, 2009
First Posted: August 25, 2009
Results First Submitted: November 18, 2011
Results First Posted: May 25, 2012
Last Update Posted: May 25, 2012