Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial

This study has been terminated.
(Imbalance in deaths favoring control arm; deaths not attributed to treatment by the blinded external medical monitor.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00414726
First received: December 21, 2006
Last updated: October 15, 2013
Last verified: October 2013
Results First Received: July 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Drug: NBO (Normobaric Oxygen)
Drug: Room Air

  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
February 2007-June 2009

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
Normobaric Oxygen Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
Room Air Room Air, inhaled at 30-45L/min via a facemask for 8 hours

Participant Flow:   Overall Study
    Normobaric Oxygen     Room Air  
STARTED     43     42  
COMPLETED     43     41  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  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
Normobaric Oxygen Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
Room Air Room Air, inhaled at 30-45L/min via a facemask for 8 hours
Total Total of all reporting groups

Baseline Measures
    Normobaric Oxygen     Room Air     Total  
Number of Participants  
[units: participants]
  43     42     85  
Age  
[units: years]
Mean ± Standard Deviation
  74.1  ± 14     73.4  ± 14     73.7  ± 14  
Gender  
[units: participants]
     
Female     27     17     44  
Male     16     25     41  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     6     6  
Not Hispanic or Latino     42     36     78  
Unknown or Not Reported     1     0     1  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     2     3  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     1     3  
White     40     39     79  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups.   [ Time Frame: 24 hours ]

2.  Primary:   Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups.   [ Time Frame: 4 hours after starting treatment ]


  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
Early termination leading to small numbers of subjects analyzed.


  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: Aneesh B. Singhal, MD
Organization: Massachusetts General Hospital
phone: 617 726 8459
e-mail: asinghal@partners.org


Publications:

Responsible Party: Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00414726     History of Changes
Other Study ID Numbers: R01NS051412, P50NS051343
Study First Received: December 21, 2006
Results First Received: July 1, 2010
Last Updated: October 15, 2013
Health Authority: United States: Food and Drug Administration