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Intra-arterial Magnesium Administration for Acute Stroke

This study has been terminated.
(No safety issues. Low enrollment secondary to negative stroke studies 2013)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502761
First Posted: January 2, 2012
Last Update Posted: August 28, 2017
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.
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
William Mack, University of Southern California
Results First Submitted: June 30, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Stroke
Intervention: Drug: Magnesium Sulfate

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Regional Intra-arterial Magnesium 0.75g

Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients

Magnesium Sulfate: Intra-arterial

Regional Intra-arterial Magnesium 1.5g

Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients

Magnesium Sulfate: Intra-arterial

Regional/ Distal (75/25%) Magnesium 1.5g

Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients

Magnesium Sulfate: Intra-arterial

Regional/ Distal (50/50%) Magnesium 1.5g

Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients

Magnesium Sulfate: Intra-arterial


Participant Flow:   Overall Study
    Regional Intra-arterial Magnesium 0.75g   Regional Intra-arterial Magnesium 1.5g   Regional/ Distal (75/25%) Magnesium 1.5g   Regional/ Distal (50/50%) Magnesium 1.5g
STARTED   4   0   0   0 
COMPLETED   4   0   0   0 
NOT COMPLETED   0   0   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.
4 patients were enrolled (regional intra-arterial Magnesium 0.75g) before the study was stopped (not due to safety concerns). They were all enrolled in the first group

Reporting Groups
  Description
Regional Intra-arterial Magnesium 0.75g

Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients

Magnesium Sulfate: Intra-arterial

Regional Intra-arterial Magnesium 1.5g

Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients

Magnesium Sulfate: Intra-arterial

Regional/ Distal (75/25%) Magnesium 1.5g

Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients

Magnesium Sulfate: Intra-arterial

Regional/ Distal (50/50%) Magnesium 1.5g

Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients

Magnesium Sulfate: Intra-arterial

Total Total of all reporting groups

Baseline Measures
   Regional Intra-arterial Magnesium 0.75g   Regional Intra-arterial Magnesium 1.5g   Regional/ Distal (75/25%) Magnesium 1.5g   Regional/ Distal (50/50%) Magnesium 1.5g   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   0   0   0   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.25  (13.25)            68.25  (13.25) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      2  50.0%               2  50.0% 
Male      2  50.0%               2  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%               0   0.0% 
Asian      0   0.0%               0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%               0   0.0% 
Black or African American      0   0.0%               0   0.0% 
White      4 100.0%               4 100.0% 
More than one race      0   0.0%               0   0.0% 
Unknown or Not Reported      0   0.0%               0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   4            4 


  Outcome Measures
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1.  Primary:   Magnesium Concentration in Region of Cerebral Ischemia   [ Time Frame: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever ]

2.  Secondary:   Number of Participants With Procedure Related Serious Adverse Event   [ Time Frame: intraprocedure, postoperative day 1, 1 month, 3 month ]


  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
The trial was terminated early (with enrollment only in the first arm) by the investigators due to low enrollment (given results of relevant studies at the time) . There were no safety concerns with the trial or the agent.


  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. William J Mack
Organization: University of Southern California
phone: 323 442 7512
e-mail: william.mack@med.usc.edu



Responsible Party: William Mack, University of Southern California
ClinicalTrials.gov Identifier: NCT01502761     History of Changes
Other Study ID Numbers: HS-11-00339
First Submitted: December 22, 2011
First Posted: January 2, 2012
Results First Submitted: June 30, 2017
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017