Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
|
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: NCT00414726 |
|
Recruitment Status :
Terminated
(Imbalance in deaths favoring control arm; deaths not attributed to treatment by the blinded external medical monitor.)
First Posted : December 22, 2006
Results First Posted : September 16, 2010
Last Update Posted : October 20, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Stroke | Drug: NBO (Normobaric Oxygen) Drug: Room Air | Phase 2 |
Stroke is the third leading cause of death and the leading cause of disability in the United States. Ischemic stroke is caused by a blockage of blood flow to one or more brain arteries, usually due to a blood clot. As a result there is a reduced supply of oxygen and other nutrients leading to permanent brain damage. Normobaric oxygen therapy (NBO, or high-flow oxygen delivered via a facemask) shows promise as a simple, widely accessible, low-cost therapy that can prevent stroke-related brain damage and extend the time window for administering the clot-busting drug t-PA (tissue plasminogen activator), which is the only acute stroke treatment approved by the Food and Drug Administration.
The primary goal of this trial is to compare the safety and therapeutic efficacy of NBO (started within 9 hours of symptom onset) to standard medical treatment with Room Air. We aim to enroll a total of 240 individuals with acute ischemic stroke less than 9 hours after symptom onset, at the Massachusetts General and Brigham and Women's Hospitals in Boston. Participants will be randomly selected to receive either room air (RA, control) or NBO (active treatment) at flow rates of 30-45L/min administered via a face mask for 8 hours. Neurological function scores and neuroimaging [magnetic resonance imaging (MRI) or computed tomography (CT) scans] will be obtained before, during, and after therapy until 90 days.
This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit individuals with stroke.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 85 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Trial of Normobaric Oxygen Therapy in Acute Ischemic Stroke |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: NBO (Normobaric Oxygen)
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
|
Drug: NBO (Normobaric Oxygen)
High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. Drug: Room Air Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. |
|
Placebo Comparator: Room Air
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
|
Drug: NBO (Normobaric Oxygen)
High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. Drug: Room Air Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. |
- 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 ]The NIHSS score ranges from 0 (best score) to 42 (worst score).
- 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 ]The NIHSS score ranges from 0 (best score) to 42 (worst score).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than or equal to 18 years.
- Acute ischemic stroke in whom treatment can potentially be started within 9 hours after symptom onset. If the symptom onset time is unknown, the time of onset will be defined as the midpoint between the time when the subject was last seen neurologically intact, and when found to have a neurological deficit.
- National Institutes of Health Stroke Scale (NIHSS) score 4 or greater.
Exclusion Criteria:
- Patients being actively considered for intravenous or intra-arterial thrombolysis will be excluded.
- Patients likely to have acute stroke intervention such as carotid endarterectomy or stent or angioplasty, hemicraniectomy, etc.
- Rapidly improving neurological deficits (transient ischemic attack).
- Known history of severe chronic obstructive pulmonary disease (Forced Expiratory Vital Capacity less than 1.0 or oxygen dependent).
- More than 3 L/min oxygen required to maintain peripheral arterial oxygen saturation above 92%.
- New York Heart Association Class III heart failure.
- Endotracheal intubation prior to enrollment or impending need for artificial ventilation.
- Coma (National Institutes of Health Stroke Scale item 1a score of 3).
- Suspected seizure at or after onset of stroke, or a known active seizure disorder.
- Blood glucose below 50 mg/dL or greater than 250 mg/dL prior to enrollment.
- Concurrent severe non-stroke medical illness requiring admission to a non-neurological intensive care unit
- Expected survival less than 90 days.
- Any condition that might limit neurological assessment or follow-up in the opinion of the investigator.
- Pre-menopausal women with a positive pregnancy blood test performed at admission.
- Inability to obtain consent from the patient or legally authorized representative.
- Active participation in another intervention study (e.g. investigational drug trial).
- Proven alternate etiology for stroke-like symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414726
| United States, Massachusetts | |
| Massachusetts General Hospital, ACC-729C | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham and Women's Hospital, 75 Francis Street | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Aneesh B Singhal, MD | Massachusetts General and Brigham & Women's Hospitals |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Aneesh B. Singhal, MD, Associate Professor of Neurology, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00414726 |
| Other Study ID Numbers: |
R01NS051412 ( U.S. NIH Grant/Contract ) P50NS051343 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 22, 2006 Key Record Dates |
| Results First Posted: | September 16, 2010 |
| Last Update Posted: | October 20, 2017 |
| Last Verified: | October 2017 |
|
ischemic stroke normobaric oxygen therapy |
|
Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |