Status:
COMPLETED
Normobaric Hyperoxia Combined With Endovascular Treatment in Acute Ischemic Stroke (OPENS-2)
Lead Sponsor:
Capital Medical University
Collaborating Sponsors:
Tianjin Huanhu Hospital
Shengli Oilfield Hospital
Conditions:
Stroke, Acute
Neuroprotection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 neurop...
Eligibility Criteria
Inclusion
- General inclusion criteria
- It conforms to the indications for endovascular thrombectomy
- 18 ≦ 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;
- Patient and family members sign informed consent. Image inclusion criteria
- 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)
Exclusion
- General exclusion criteria
- 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;
- Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
- Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
- A history of severe allergies to contrast agents;
- There are any other conditions that are not suitable for endovascular treatment.
- Image exclusion criteria
- CTA/MRAshows excessive bending of blood vessels, which may hinder the delivery of the device;
- Suspected cerebrovascular inflammation based on medical history and CTA/MRA;
- Suspected aortic dissection based on medical history and CTA/MRA
- CTA/MRA confirmed multi-vascular area occlusion (such as bilateral anterior circulation or anterior/posterior circulation), or bilateral infarction or multi- regional infarction;
- CTA/MRAconfirmed moyamoya disease or moyamoya syndrome;
- CT/MRI confirmed the obvious effect of midline shift
- CT/MRI confirmed the presence of intracranial tumors
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT04681651
Start Date
April 22 2021
End Date
May 5 2023
Last Update
July 6 2023
Active Locations (1)
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1
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100069