Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage

NCT06711302 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2024009
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of mRS (0-2)

  Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.

  90±7 days

Secondary Outcomes (5)

• Proportion of mRS (0-1)

  90±7 days

• mRS Score as ordinal variable

  7±1 days

• mRS Score as ordinal variable

  30±7 days

• Cognitive function score as ordinal variable

  7±1 days

• The complete blood count

  During hospitalization

Study Arms (2)

Sham group

SHAM COMPARATOR

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

Device: Sham RIC

RIC Group

EXPERIMENTAL

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

Device: Remote Ischemic Conditioning treatment instrument

Interventions

Sham RIC DEVICE

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

Sham group

Remote Ischemic Conditioning treatment instrument DEVICE

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

RIC 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:

• 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);
• The Hunt-Hess grade is 2-3 at admission;
• Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;
• The responsible aneurysm has been treated by endovascular interventional therapy;
• ≤ age ≤80 years old;
• Informed consent must be obtained from participants or legally authorized representatives.

You may not qualify if:

• Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;
• Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;
• With severe comorbidities and a life expectancy of less than 90 days;
• Refractory hypertension (Systolic blood pressure\> 180 mmHg or diastolic blood pressure \>110 mmHg);
• Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;
• Concurrent participation in another protocol investigating 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, China

Location

Related Publications (1)

• 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.

  PMID: 40789732 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 2, 2024
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of the main trial results, subject to legal and ethical approvals.
• Access Criteria: Approved investigators will have access to deidentified data by contacting the corresponding author.

Locations

CN (1)