Normobaric Hyperoxia Combined With Endovascular Treatment in Acute Ischemic Stroke (OPENS-2)

NCT04681651 | Completed Phase 2

• 1 other identifier: OPENS-2
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

The current endovascular treatment has increased the recanalization rate to more than 90%. Even so, the prognosis rate of stroke is still less than 50%. Our previous research confirmed that the neuroprotective effect of Normobaric Hyperoxia (NBO) from multiple perspectives. However, the clinical study on NBO was not satisfactory, which might be due to the absence of vascular recanalization therapy. Therefore, The investigators conducted this RCT study to further explore the Efficacy and safety of NBO combined with endovascular treatment in patients with acute ischemic stroke.

Conditions

Stroke, Acute; Neuroprotection

Keywords

Normobaric hyperoxia; Endovascular treatment; Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS) score

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

  90 ± 14 days after randomization

Secondary Outcomes (27)

• Cerebral infarct volume

  24-48h after randomization

• The proportion of good prognosis

  90 ± 14 days after randomization

• The proportion of functional independence

  90 ± 14 days after randomization

• The proportion of severe disability

  90 ± 14 days after randomization

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

  24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization

Study Arms (2)

NBO group

EXPERIMENTAL

Normobaric Hyperoxia combined with endovascular mechanical thrombectomy

Drug: Normobaric Hyperoxia; Procedure: Endovascular Thrombectomy

Control group

PLACEBO COMPARATOR

Inhale air placebo plus endovascular mechanical thrombectomy

Drug: Sham Normobaric Hyperoxia; Procedure: Endovascular Thrombectomy

Interventions

Normobaric Hyperoxia DRUG

Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask 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.

Also known as: NBO

NBO group

Sham Normobaric Hyperoxia DRUG

For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) 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%；

Also known as: Sham NBO

Control group

Endovascular Thrombectomy PROCEDURE

EVT is the international guidelines for the treatment of acute ischemic stroke with lage vessel occlusion.

Also known as: EVT

Control group; NBO group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• It conforms to the indications for endovascular thrombectomy
• ≦ Age ≦ 80 years old.
• The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; 10≤NIHSS≤20；
• (Level of consciousness) NIHSS score 0 or 1;
• The time from onset to randomization is within 6 hours of onset;
• The mRS score before stroke is 0-1;
• \. Preoperative CT or MR or DSA angiography found large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that were consistent with symptoms and signs; 2. ASPECT score ≥ 6 points 3. \<1/3 MCA area involvement (confirmed by CT or MRI)

You may not qualify if:

• Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
• Seizures at stroke onset;
• Intracranial hemorrhage;
• Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR \> 3.0 or PTT \> 3 times normal;
• Platelet count of less than 100,000 per cubic millimeter;
• Severe hepatic or renal dysfunction;
• Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg)
• Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
• 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;
• Life expectancy\<90 days;
• Patients who could not complete the 90-day follow-up;
• Evidence of intracranial tumor;

Sponsors & Collaborators

• Capital Medical University: lead
• Tianjin Huanhu Hospital: collaborator
• Shengli Oilfield Hospital: collaborator
• Beijing Fengtai You'anmen Hospital: collaborator
• Jiujiang University Affiliated Hospital: collaborator
• Zhangzhou Municipal Hospital of Fujian Province: collaborator
• Baotou Central Hospital: collaborator
• Luoyang Central Hospital: collaborator
• Nanyang Central Hospital: collaborator
• Qingdao Central Hospital: collaborator
• The Third People's Hospital of Jinan: collaborator
• Rizhao People's Hospital: collaborator
• Anyang People's Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• Dalian Municipal Central Hospital: collaborator
• Zhoukou Central Hospital: collaborator
• Nanshi Hospital of Nanyang: collaborator
• The second Nanning People's Hospital: collaborator
• Zhumadian Central Hospital: collaborator
• Taizhou Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Related Publications (1)

• Li W, Lan J, Wei M, Liu L, Hou C, Qi Z, Li C, Jiao L, Yang Q, Chen W, Liu S, Yue X, Dong Q, Yuan H, Gao Z, Wu X, Wen C, Li T, Jiang C, Li D, Chen Z, Shi J, Shi W, Yuan J, Qin Y, Li B, Fisher M, Feng W, Liu KJ, Ji X; OPENS-2 Investigators. Normobaric hyperoxia combined with endovascular treatment for acute ischaemic stroke in China (OPENS-2 trial): a multicentre, randomised, single-blind, sham-controlled trial. Lancet. 2025 Feb 8;405(10477):486-497. doi: 10.1016/S0140-6736(24)02809-5.

  PMID: 39922675 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xunming Ji, MD,PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 23, 2020
• Study Start: April 22, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-03

Locations

CN (1)