Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT06711302

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-04-01

Brief Summary

Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH.

Remote ischemic conditioning(RIC) has gained considerable attention in the treatment of stroke, particularly ischemic stroke, with numerous studies demonstrating its potential to enhance neurological outcomes compared to conventional treatments alone.RIC for the treatment of SAH is an investigative strategy in its initial stages. The neuroprotective effects of RIC, particularly its potential to preserve cranial nerve function and ameliorate neurological deficits, confer significant value in the treatment of SAH patients.

The precise manner in which SAH patients may benefit from RIC treatment, and the mechanisms by which it improves neurological function, remain to be fully understood. Consequently, randomized controlled trials are necessary to validate the efficacy of RIC in this patient population and to delineate the optimal therapeutic protocols for its application.

Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of SAH.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sham group

Guideline-based therapy+Sham RIC is given twice a day with 60mmHg pressure.

Group Type: SHAM_COMPARATOR

Sham RIC

Intervention Type: DEVICE

Remote Ischemic Conditioning is given twice a day with 60mmHg pressure.

RIC Group

Guideline-based therapy+RIC RIC is given twice a day with 200mmHg pressure.

Group Type: EXPERIMENTAL

Remote Ischemic Conditioning treatment instrument

Intervention Type: DEVICE

Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.

Interventions

Sham RIC

Remote Ischemic Conditioning is given twice a day with 60mmHg pressure.

Intervention Type: DEVICE

Remote Ischemic Conditioning treatment instrument

Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with aneurysmal subarachnoid hemorrhage confirmed by imaging examination (diagnosed by computed tomography and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography);

2. The Hunt-Hess grade is 2-3 at admission;

3. Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;

4. The responsible aneurysm has been treated by endovascular interventional therapy;

5. 18≤ age ≤80 years old;

6. Informed consent must be obtained from participants or legally authorized representatives.

Exclusion Criteria

1. Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;

2. Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;

3. With severe comorbidities and a life expectancy of less than 90 days;

4. Refractory hypertension (Systolic blood pressure> 180 mmHg or diastolic blood pressure >110 mmHg);

5. Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;

6. Concurrent participation in another protocol investigating 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

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital

Beijing, , China

Countries

China

Central Contacts

Aihua Liu, Doctor

Role: CONTACT

liuaihuadoctor@ccmu.edu.cn

+8615901398688

Facility Contacts

Aihua Liu, Doctor

Role: primary

liuaihuadoctor@ccmu.edu.cn

+15901398688

References

Jin T, Niu H, Liu L, Yin Y, Zhao W, Feng X, Xu L, Hess DC, Liu A, Ji X. Remote ischaemic conditioning for efficacy in patients with aneurysmal subarachnoid haemorrhage (REPAIR): protocol for a multicentre, randomised, double-blind, sham-controlled, parallel-group trial. BMJ Open. 2025 Aug 11;15(8):e101350. doi: 10.1136/bmjopen-2025-101350.

Reference Type: DERIVED

PMID: 40789732 (View on PubMed)

Other Identifiers

HX-A-2024009

Identifier Type: -

Identifier Source: org_study_id