Stroke, Acute Clinical Trial
Official title:
A Randomized Controlled Trial Assessing the Efficacy and Safety of Normobaric Hyperoxia for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment
NCT number | NCT04681651 |
Other study ID # | OPENS-2 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 22, 2021 |
Est. completion date | May 5, 2023 |
Verified date | March 2023 |
Source | Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 282 |
Est. completion date | May 5, 2023 |
Est. primary completion date | May 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: General inclusion criteria 1. It conforms to the indications for endovascular thrombectomy 2. 18 ? Age ? 80 years old. 3. The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; 10=NIHSS=20; 4. (Level of consciousness) NIHSS score 0 or 1; 5. The time from onset to randomization is within 6 hours of onset; 6. The mRS score before stroke is 0-1; 7. 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 Criteria: - General exclusion criteria 1. Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization; 2. Seizures at stroke onset; 3. Intracranial hemorrhage; 4. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal; 5. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal; 6. Platelet count of less than 100,000 per cubic millimeter; 7. Severe hepatic or renal dysfunction; 8. Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg) 9. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 10. Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; 11. >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines; 12. Medically unstable; 13. Life expectancy<90 days; 14. Patients who could not complete the 90-day follow-up; 15. Evidence of intracranial tumor; 16. Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation; 17. Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen. 18. A history of severe allergies to contrast agents; 19. There are any other conditions that are not suitable for endovascular treatment. Image exclusion criteria 1. CTA/MRAshows excessive bending of blood vessels, which may hinder the delivery of the device; 2. Suspected cerebrovascular inflammation based on medical history and CTA/MRA; 3. Suspected aortic dissection based on medical history and CTA/MRA 4. CTA/MRA confirmed multi-vascular area occlusion (such as bilateral anterior circulation or anterior/posterior circulation), or bilateral infarction or multi- regional infarction; 5. CTA/MRAconfirmed moyamoya disease or moyamoya syndrome; 6. CT/MRI confirmed the obvious effect of midline shift 7. CT/MRI confirmed the presence of intracranial tumors |
Country | Name | City | State |
---|---|---|---|
China | Xuan Wu Hospital,Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University | Anyang People's Hospital, Baotou Central Hospital, Beijing Fengtai You'anmen Hospital, Dalian Municipal Central Hospital, Jiujiang University Affiliated Hospital, Luoyang Central Hospital, Nanshi Hospital of Nanyang, Nanyang Central Hospital, Qingdao Central Hospital, Rizhao People's Hospital, Second Affiliated Hospital of Nanchang University, Shanghai 10th People's Hospital, Shengli Oilfield Hospital, Taizhou Hospital, The second Nanning People's Hospital, The Third People's Hospital of Jinan, Tianjin Huanhu Hospital, Zhangzhou Municipal Hospital of Fujian Province, Zhoukou Central Hospital, Zhumadian Central Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Cerebral infarct volume | The infarct volume of cerebral infarct is evaluated by MRI or CT | 24-48h after randomization | |
Secondary | The proportion of good prognosis | defined by mRS 0-2 | 90 ± 14 days after randomization | |
Secondary | The proportion of functional independence | defined by mRS 0-1 | 90 ± 14 days after randomization | |
Secondary | The proportion of severe disability | defined by mRS 4-6 | 90 ± 14 days after randomization | |
Secondary | Scores assessed by National Institutes of Health Stroke Scale(NIHSS) | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits | 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization | |
Secondary | The proportion of neurological function improvement | = 4 point reduction in NIHSS score from baseline | 24 ± 6 hours after randomization | |
Secondary | Successful vessel recanalization | Successful vessel recanalization is defined by eTICI 2b/2c/3 on final angiogram. Extended treatment in cerebral ischaemia (eTICI) score range from 0 to 3, with higher scores indicating better reperfusion | Immediately after procedure | |
Secondary | Vessel recanalization | Vessel recanalization is evaluated by CTA or MRA and assessed by AOL grades. Arterial Occlusive Lesion (AOL) range from 0 to 3, with higher scores indicating better recanalization | 24 ± 6 hours after randomization | |
Secondary | Arterial oxygen partial pressure | Laboratory indicators, obtained by arterial blood gas analysis | after 4 hours of oxygen therapy | |
Secondary | Barthel Index (BI) | the BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis) | 90 ± 14 days after randomization | |
Secondary | EuroQol five dimensions questionnaire(EQ-5D) | The score ranges from 0 to 100, with higher scores indicating optimal health | 90 ± 14 days after randomization | |
Secondary | Days of hospitalization | Length of stay in hospital | 90 ± 14 days after randomization | |
Secondary | All-cause mortality | Safety endpoint; the proportion of all patients who died in each group | 90 ± 14 days after randomization | |
Secondary | Serious adverse events | Safety endpoint; the proportion of serious adverse events in each group | 90 ± 14 days after randomization | |
Secondary | Stroke-related mortality | Safety endpoint; the proportion of stroke related deaths in each group | 90 ± 14 days after randomization | |
Secondary | Oxygen-related adverse events | Safety endpoint; the proportion of oxygen-related adverse events in each group, including severe lung infection, pneumothorax, atelectasis, respiratory failure, acute respiratory distress syndrome, and cardiopulmonary arrest | 90 ± 14 days after randomization | |
Secondary | Adverse events of special interest | Safety endpoint; the proportion of adverse events of special interest in each group, including malignant brain edema, perioperative myocardial infarction, and acute heart failure | 90 ± 14 days after randomization | |
Secondary | Symptomatic intracranial hemorrhage | Safety endpoint; according to ECASS II definition | 24 ± 6 hours after randomization | |
Secondary | Any intracranial hemorrhage | Safety endpoint; the proportion of any intracranial hemorrhage in each group | 24 ± 6 hours after randomization | |
Secondary | Early neurological deterioration (END) | Safety endpoint; defined as =4 point increase in NIHSS score from baseline | 24 ± 6 hours after randomization | |
Secondary | Systolic and diastolic blood pressure | Safety endpoint; vital signs | 24 ± 6 hours after randomization | |
Secondary | Heart rate | Safety endpoint; vital signs | 24 ± 6 hours after randomization | |
Secondary | Respiratory rate | Safety endpoint; vital signs | 24 ± 6 hours after randomization | |
Secondary | Oxygen saturation | Safety endpoint; vital signs | 24 ± 6 hours after randomization | |
Secondary | PH of arterial blood gas analysis | Safety endpoint | after 4 hours of oxygen therapy | |
Secondary | PaCO2 of arterial blood gas analysis | Safety endpoint | after 4 hours of oxygen therapy | |
Secondary | Lactic acid of arterial blood gas analysis | Safety endpoint | after 4 hours of oxygen therapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
Completed |
NCT03679637 -
Tablet-based Aphasia Therapy in the Acute Phase After Stroke
|
N/A | |
Completed |
NCT03574038 -
Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke
|
N/A | |
Completed |
NCT03633422 -
Evaluation of Stroke Patient Screening
|
||
Completed |
NCT04088578 -
VNS-supplemented Motor Retraining After Stroke
|
N/A | |
Withdrawn |
NCT04991038 -
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
|
N/A | |
Not yet recruiting |
NCT05534360 -
Tenecteplase Treatment in Ischemic Stroke Registry
|
||
Not yet recruiting |
NCT04105322 -
Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
|
N/A | |
Withdrawn |
NCT05786170 -
ERILs Und SNILs Unter SOC
|
N/A | |
Recruiting |
NCT03132558 -
Contrast Induced Acute Kidney in Patients With Acute Stroke
|
N/A | |
Completed |
NCT02893631 -
Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
|
||
Active, not recruiting |
NCT02274727 -
Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study
|
||
Completed |
NCT02225730 -
Imaging Collaterals in Acute Stroke (iCAS)
|
||
Terminated |
NCT01705353 -
The Role of HMGB-1 in Chronic Stroke
|
N/A | |
Active, not recruiting |
NCT01581502 -
SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)
|
N/A | |
Completed |
NCT01182818 -
Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
|
N/A | |
Completed |
NCT00761982 -
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
|
Phase 1/Phase 2 | |
Completed |
NCT00535197 -
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
|
Phase 1/Phase 2 | |
Terminated |
NCT00132509 -
FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
|
Phase 2 | |
Recruiting |
NCT05760326 -
Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients
|