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Completed

NCT Number: NCT03620370

Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke

NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to evaluate the safety and efficiency of NBO(Normobaric hyperoxia) in the acute ischemic stroke patients who received endovascular treatment. Looking for more clinical evidence for the ischemic stroke patients who will be treated with NBO in the future.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu hospital;Capital Medical University

Beijin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age≥18 and ≤ 80;
  • Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1-segment of the MCA;
  • Acute ischemic stroke where patient is ineligible for intravenous thrombolytic treatment or the treatment is contraindicated, or where patient has received intravenous thrombolytic therapy without recanalization;
  • Patient treatable within 6 hours of symptom onset;or it has been more than 6 hours but not more than 24 hours,and imaging confirmed the existence of ischemic penumbra;
  • NIHSS score≥6分
  • Alberta Stroke Program Early CT score (ASPECTS) of 7-10 on non-contrast CT;
  • Informed consent obtained;

Exclusion criteria

  • Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization;
  • Seizures at stroke onset;
  • Intracranial hemorrhage;
  • Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits;
  • Symptoms rapidly improving;
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
  • Platelet count of less than 100,000 per cubic millimeter;
  • CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere);
  • severe hepatic or renal dysfunction;
  • active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
  • >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)﹥95% as per current stroke management guidelines;
  • medically unstable;
  • inability to obtain informed consent;
  • Life expectancy<90 days;
  • Pregnant or breast-feeding women;
  • Unwilling to be followed up or poor compliance for treatment;
  • Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
  • Evidence of intracranial tumor;
  • Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);

Treatment and study plan

Normobaric oxygen therapy

Drug

In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.

Primary outcomes

  1. Cerebral infarct volume

    Time frame: 24-48h after randomization

    Infarct volume is evaluated mainly through brain MRI(DWI)

Secondary outcomes

  1. levels of blood biomarkers

    Time frame: baseline; 24 ± 6 hours, 7 ± 2 days

    Biomarkers for evaluation of BBB damage and brain injury:NSE、S100B、occludin、 claudin-5、MMP-9

  2. modified Rankin Scale score (mRS)

    Time frame: 30 ± 5 days, 90 ± 10 days after randomization

    secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

  3. The good prognosis at 90 days assessed by modified Rankin scale (mRS).

    Time frame: 90 ± 10 days after randomization

    secondary clinical efficacy endpoint;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;

  4. Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

    Time frame: 2 hours ± 15 minutes, 24 ± 6 hours, 7 ± 2 days, 30 ± 5 days after randomization ]

    secondary clinical efficacy endpoint; the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits

  5. Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours

    Time frame: from baseline to 24 ± 6 hours

    secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

  6. Improvement of neurologic function after 24h

    Time frame: 24 ± 6 hours;

    NIHSS score decreased by more than 4 points or NIHSS score was 0;secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

  7. Barthel Index (BI)

    Time frame: 30 ± 5 days, 90 ± 10 days after randomization

    secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

  8. Revascularization on 24-hour follow-up imaging

    Time frame: 24 (12 to 36) hours;

    secondary imaging efficacy endpoint;

  9. 24-hour neurologic deterioration;

    Time frame: 24 ± 6 hours;

    NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;

  10. any intracranial hemorrhage on 24-hour follow-up imaging

    Time frame: 24 (12 to 36) hours

    imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification

  11. Symptomatic Intracerebral Hemorrhage

    Time frame: 24 (12 to 36) hours

    imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification

  12. Mortality and Stroke recurrence

    Time frame: 90 ± 10 days after randomization

    clinical safety endpoint;

  13. Survival rates

    Time frame: 7 ± 2 days, 90 ± 10 days after randomization

    secondary clinical efficacy endpoint;

  14. TICI (Thrombolysis in Cerebral Infarction perfusion scale grade)

    Time frame: Time Frame: 4 hours ± 15 minutes

    secondary imaging efficacy endpoint;

  15. The infarct volume on 24-hour follow-up imaging

    Time frame: 24 (12 to 36) hours;

    The infarct volume of cerebral infarct is evaluated by cranial CT;

  16. mRS4-6

    Time frame: 90 ± 10 days after randomization

    secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

Other outcomes

  1. Subgroup analysis of infarct volume

    Time frame: 24-48h after randomization

    Stratify according to different risk factors:ASPECT; NIHSS; age;Ischemic penumbra volume; Site of occlusion; Time from stroke onset to randomization;Ischemic penumbra volume

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

The Safety and Efficacy of Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke:A Randomized, Controlled Pilot Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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