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The investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. The safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. The investigators therefore conducted this RCT study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional Hypothermia group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Hypothermia | Other | Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of any major adverse events | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of intracerebral hemorrhage | 24 hours | |
| Rate of symptomatic intracerebral hemorrhage | 24 hours | |
| Rate of death |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of vessel recanalization after treatment | Assessed by CTA or MRA | 24 hours |
| The temperature change of the tympanic membrane on the ipsilateral side of the vascular occlusion within one hour after endovascular treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD | Contact | 01083199439 | jixm@ccmu.edu.cn | |
| Chuanjie Wu, MD | Contact | wuchuanjie8557@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 90 days |
| 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 hours |
| Final infarct volume | measured on 5-7 days CT (or MRI if available) | 5-7 days |
| NIHSS | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. | 7 days or discharge |
| Modified Rankin scale | The modified Rankin scale is a 7-point scale ranging from 0 (no symptoms) to 6 (death). A score of 2 or less indicates functional independence. | 90 days |
| 1 hour |
| The patient's rectal temperature within one hour after endovascular treatment | 1 hour |
| Lu He hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 101149 | China |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |