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

NCT06819657 | Recruiting DMC

• 1 other identifier: HX-B-2024033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• mRS Score as ordinal variable

  7±1 days post-enrollment in the study

• mRS Score as ordinal variable

  30±7 days post-enrollment in the study

• incidence rate of aSAH complications

  From enrollment to 90 days post-enrollment

Study Arms (2)

control group

OTHER

Guideline-based therapy

Other: Guideline-based therapy

RIC Group

EXPERIMENTAL

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

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

Interventions

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

RIC Group

Guideline-based therapy OTHER

Guideline-based therapy

RIC Group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41356238 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Cerebrovascular Disorders; Brain Diseases; Stroke; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Central Nervous System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aihua Liu, Doctor

CONTACT

+8615901398688; liuaihuadoctor@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: March 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

CN (1)