An interventional study of oxygen in Stroke, Acute, Hypoxia-Ischemia, Brain and ENDOVASCULAR TREATMENT, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Capital Medical University · Not applicable, Interventional, and Treatment
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Among 33 studies in Stroke by Capital Medical University — 7 open to participants now, 10 under way, 3 of them phase 3. Stroke · Capital Medical University.
Among the 33 studies in Stroke by Capital Medical University, this one is the 10th largest by enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2021, is one of 12 with no phase, and was the 17th registered.
8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.
Browse Stroke studies →7 of the 33 studies in Stroke by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:
Capital Medical University · Sites in China
Ages 18–80
Capital Medical University · Sites in China
Ages 18+
Capital Medical University · Sites in China
Ages 18+
Capital Medical University · Sites in China
Ages 18–80
Capital Medical University · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 7
First in 2010; this study’s year is marked. 4 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 282 is above the median of 49 across 6,027 interventional studies indexed under Stroke.
Median enrollment 168 across the 28 interventional studies, 500 across the 5 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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Capital Medical University is the lead sponsor of 296 studies on the registry; 90 are open to participants now.
5 of the studies in Stroke by Capital Medical University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07513233Capital Medical UniversityAnisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL) | 2026-11-20 |
| NCT07139314Capital Medical UniversityTiming of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2 | 2026-11-30 |
| NCT07800572Capital Medical UniversityAnisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL-2) | 2026-12-31 |
| NCT07785492Capital Medical UniversityArtificial Intelligence Support for Stroke | 2026-12-31 |
| NCT07139301Capital Medical UniversityTiming of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation | 2027-01-17 |
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Among the 33 studies in Stroke by Capital Medical University, from their registry updates:
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The overall incidence of good outcome for AIS following endovascular treatment is only proximately 50%. Whether NBO was safe and effective to improve acute ischemic stroke prognosis is still unclear. The investigators' hypothesis is thatNBO is a safe and effective strategy to improve longterm outcome in AIS patients undergoing endovascular treatment.
NBO therapy is to deliver high flow oxygen (10L/min) through an oxygen storage mask. This treatment should be started in the emergency room immediately after the patient is randomized into the group, and oxygen should be continued for 4 hours.
In previous clinical studies of NBO, patients who have not receive revascularization often choose NBO for 8 hours, and studies have concluded that oxygen inhalation for more than 10 hours may bring about the risk of oxygen poisoning. However, a too short treatment time may not bring benefits. Secondly, ideally, we want to ensure that stroke patients receive NBO treatment before achieving reperfusion to protect the ischemic brain tissue, and add 1-2 hours after reperfusion. In the clinical environment after the patient arrives in the emergency department, it takes 2-3 hours to complete the revascularization process. Therefore, we believe that 4 hours of oxygen inhalation is reasonable. And our single-center study also supports that NBO treatment for 4 hours is beneficial.
The specific content is as follows: In the emergency room, patients who are assessed for suspected large blood vessels of acute anterior circulation will be randomized after signing the informed consent. If the subject is randomly divided into NBO+ET group, by putting the patient on Oxygen mask, and then immediately give oxygen (10L/min). NBO treatment is no later than half an hour after randomization. Oxygen comes from the hospital's oxygen center and is transported through wall pipes (oxygen concentration: 100%). The oxygen mask and the wall oxygen are connected by a 1.5 meter long oxygen pipe. When the patient is transferred to the operating room, we provide oxygen through a portable oxygen cylinder (capacity: 4L). In addition, in the operating room and intensive care unit, patients continue to be given wall oxygen therapy until the oxygen inhalation lasts for 4 hours. The arterial blood gas was drawn after 4 hours of oxygen inhalation. The control group directly inhales room air through the patient's nasal cavity without using any equipment. At the same time, patients in the control group were also drawn blood gas analysis at corresponding time points (approximately 4 hours after randomization).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30minutes after admission) at a ventilation rate of 10L/min using a sealed non-ventilating oxygen storagemask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
Other: oxygen
For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%
Other: oxygen
deliver high flow oxygen (10L/min)
Modified Rankin Scale
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)
Time frame: 1 year ± 30 days after randomization
EuroQol- 5 Dimension (EQ-5D)
EuroQol five dimensions questionnaire (EQ-5D)EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: 1 year ± 30 days after randomization
The proportion of good prognosis
the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death);The ratio of 0 to 2
Time frame: 1 year ± 30 days after randomization
Functional independence
The Proportion of mRS 0-1
Time frame: 1 year ± 30 days after randomization
The Proportion of mRS 0-3
secondary clinical efficacy endpoint
Time frame: 1 year ± 30 days after randomization
Barthel Index (BI)
he BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);
Time frame: 1 year ± 30 days after randomization
All-cause mortality
clinical safety endpoint;
Time frame: 1 year ± 30 days after randomization
New major vascular events
clinical safety endpoint; Major vascular events include fatal or nonfatal cardiac events, fatal or nonfatal stroke, or fatal or nonfatal major peripheral arterial or thrombo-embolic events.
Time frame: 1 year ± 30 days after randomization
kaplan-meier curve
clinical efficacy endpoint
Time frame: 1 year ± 30 days after randomization
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Feb 2024, 33 months.
Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 33 months is above that.
Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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