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This study was designed to evaluate the safety and efficacy of remote ischemic conditioning (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) following surgical clipping.
Aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when a cerebral aneurysm ruptures, causing bleeding into the subarachnoid space. Surgical clipping of the aneurysm is a standard procedure used to stop the bleeding and prevent re-rupture, thereby stabilizing the patient's condition.
Remote ischemic conditioning (RIC) is a non-invasive treatment that involves using a blood pressure cuff to induce brief, temporary cycles of ischemia and reperfusion in a limb. Research suggests that this process may confer systemic protective effects, potentially improving recovery from brain injury or surgery. Although RIC has shown potential to improve outcomes in patients with other neurological conditions, its effect on patients with aSAH who undergo surgical clipping remains unclear.
This study will evaluate whether RIC can reduce complications, improve neurological function, and enhance overall recovery in these patients. The findings will help determine whether RIC should be incorporated into the standard treatment regimen for aSAH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Other | Guideline-based therapy |
|
| RIC Group | Experimental | Guideline-based therapy + RIC (200 mmHg, bid, 7d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic Conditioning Treatment Instrument | Device | Remote ischemic conditioning (RIC) was administered twice daily to the unilateral lower limb using a blood pressure cuff inflated to 200 mmHg for 7 consecutive days post-clipping |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of mRS (0-2) | Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis. | 90±7 days post-enrollment in the study |
| incidence rate of RIC adverse events | RIC adverse events mainly include: limb pain, skin damage, deep vein thrombosis, transient hypertension, etc. | From enrollment to the end of RIC at 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| mRS Score as ordinal variable | Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis. | 7±1 days post-enrollment in the study |
| mRS Score as ordinal variable | Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aihua Liu, Doctor | Contact | +8615901398688 | liuaihuadoctor@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41356238 | Derived | Xu L, Jin T, Niu H, Yin Y, Yan K, Guan H, Liu A. Remote ischemic conditioning for safety, feasibility and preliminary efficacy of patients with aneurysmal subarachnoid hemorrhage after aneurysm clipping, design, and protocol for an open-label, evaluator blinding randomized controlled trial. Front Neurol. 2025 Nov 20;16:1650773. doi: 10.3389/fneur.2025.1650773. eCollection 2025. |
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| Guideline-based therapy | Other | Guideline-based therapy |
|
| 30±7 days post-enrollment in the study |
| incidence rate of aSAH complications | The complications of aneurysmal subarachnoid hemorrhage mainly include cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, rebleeding, etc. | From enrollment to 90 days post-enrollment |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D020521 | Stroke |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002493 | Central Nervous System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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