Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping

Capital Medical University

Status: Enrolling

Conditions: Stroke; Subarachnoid Hemorrhage, Aneurysmal; Nervous System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases

Treatments: Device: Remote Ischemic Conditioning Treatment Instrument; Other: Guideline-based therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06819657

HX-B-2024033

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Imaging examination confirmed aneurysmal subarachnoid hemorrhage.
2. Responsible aneurysms received craniotomy clipping within 24 hours.
3. 18≤ age ≤80 years old.
4. Informed consent of the participant or legally authorized representative

Exclusion criteria

1. Patients with other types of cerebral hemorrhage.
2. Prior neurological impairment (mRS Score >1) or mental illness may confuse neurological or functional assessment.
3. Severe comorbidities with a life expectancy of less than 90 days.
4. Refractory hypertension (systolic blood pressure 180>mmHg or diastolic blood pressure 110>mmHg).
5. RIC contraindications: severe soft tissue injury of lower limbs.
6. Simultaneously participate in another research program to study a different experimental therapy.
7. Any condition that the investigator believes may increase the patient's risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

control group

Other group

Description:

Guideline-based therapy

Treatment:

Other: Guideline-based therapy

RIC Group

Experimental group

Description:

Guideline-based therapy + RIC (200 mmHg, bid, 7d)

Treatment:

Other: Guideline-based therapy

Device: Remote Ischemic Conditioning Treatment Instrument