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

NCT ID: NCT06819657

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

Guideline-based therapy

Group Type OTHER

Guideline-based therapy

Intervention Type OTHER

Guideline-based therapy

RIC Group

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

Group Type EXPERIMENTAL

Remote Ischemic Conditioning Treatment Instrument

Intervention Type 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

Guideline-based therapy

Intervention Type OTHER

Guideline-based therapy

Interventions

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Remote Ischemic Conditioning Treatment Instrument

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

Intervention Type DEVICE

Guideline-based therapy

Guideline-based therapy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Aihua Liu, Doctor

Role: CONTACT

+8615901398688

Facility Contacts

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Aihua Liu, Doctor

Role: primary

+8615901398688

Other Identifiers

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HX-B-2024033

Identifier Type: -

Identifier Source: org_study_id

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