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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:
ClinicalTrials.gov Identifier:
NCT00414726
First Posted: December 22, 2006
Last Update Posted: October 20, 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:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital
Results First Submitted: July 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[Units: Participants]
 43   42   85 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.1  (14)   73.4  (14)   73.7  (14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      27  62.8%      17  40.5%      44  51.8% 
Male      16  37.2%      25  59.5%      41  48.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      6  14.3%      6   7.1% 
Not Hispanic or Latino      42  97.7%      36  85.7%      78  91.8% 
Unknown or Not Reported      1   2.3%      0   0.0%      1   1.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   2.3%      2   4.8%      3   3.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   4.7%      1   2.4%      3   3.5% 
White      40  93.0%      39  92.9%      79  92.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      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
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Time Frame AEs were collected until the final visit at 3 months (range, 75-110 days). All deaths until day 110 were included.
Additional Description Total 24 deaths: 7 RA, 17 NBO. The blinded external medical monitor did not adjudicte any death as "definitely" or "probably" related to therapy. One death in each arm was adjudicated as "possibly" related to therapy; 6 deaths in the Room Air arm and 16 deaths in the NBO arm, were adjudicated as "unlikely or unrelated" to therapy.

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

Serious Adverse Events
    Normobaric Oxygen   Room Air
Total, Serious Adverse Events     
# participants affected / at risk   24/43 (55.81%)   20/41 (48.78%) 
Cardiac disorders     
Cardiac Arrhythmia     
# participants affected / at risk   1/43 (2.33%)   3/41 (7.32%) 
Cardiac General     
# participants affected / at risk   3/43 (6.98%)   2/41 (4.88%) 
General disorders     
Constitutional Symptoms     
# participants affected / at risk   0/43 (0.00%)   1/41 (2.44%) 
Death     
# participants affected / at risk   17/43 (39.53%)   7/41 (17.07%) 
Hemorrhage/Bleeding     
# participants affected / at risk   4/43 (9.30%)   0/41 (0.00%) 
Pain     
# participants affected / at risk   1/43 (2.33%)   0/41 (0.00%) 
Hepatobiliary disorders     
Hepatobiliary/Pancreas     
# participants affected / at risk   1/43 (2.33%)   0/41 (0.00%) 
Infections and infestations     
Infection     
# participants affected / at risk   2/43 (4.65%)   1/41 (2.44%) 
Investigations     
Metabolic/Laboratory     
# participants affected / at risk   0/43 (0.00%)   1/41 (2.44%) 
Nervous system disorders     
Neurology     
# participants affected / at risk   8/43 (18.60%)   3/41 (7.32%) 
Renal and urinary disorders     
Renal/Genitourinary     
# participants affected / at risk   0/43 (0.00%)   2/41 (4.88%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary/Upper Respiratory     
# participants affected / at risk   3/43 (6.98%)   2/41 (4.88%) 
Vascular disorders     
Vascular     
# participants affected / at risk   0/43 (0.00%)   2/41 (4.88%) 




  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 ( U.S. NIH Grant/Contract )
P50NS051343 ( U.S. NIH Grant/Contract )
First Submitted: December 21, 2006
First Posted: December 22, 2006
Results First Submitted: July 1, 2010
Results First Posted: September 16, 2010
Last Update Posted: October 20, 2017