Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage (REPAIR)

Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage: a Multi-center, Randomized, Double-blind, Sham-controlled, Parallel-group Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Subarachnoid Hemorrhage
• Intervention / Treatment: Device: Sham RIC; Device: Remote Ischemic Conditioning treatment instrument

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aihua Liu, Doctor; Phone Number: +8615901398688; Email: liuaihuadoctor@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital
    • Contact: Aihua Liu, Doctor; Phone Number: +15901398688; Email: liuaihuadoctor@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham group; Guideline-based therapy+Sham RIC is given twice a day with 60mmHg pressure.	Device: Sham RIC; Remote Ischemic Conditioning is given twice a day with 60mmHg pressure.
Experimental: RIC Group; Guideline-based therapy+RIC RIC is given twice a day with 200mmHg pressure.	Device: Remote Ischemic Conditioning treatment instrument; Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mRS (0-2)	Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.	90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of mRS (0-1)	Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.	90±7 days
mRS Score as ordinal variable	Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.	7±1 days
mRS Score as ordinal variable	Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.	30±7 days
Cognitive function score as ordinal variable	Montreal Cognitive Assessment, MoCA. The total score is 30, with higher scores indicating better cognitive function.	7±1 days
The complete blood count	up to 30 days	During hospitalization

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Pathologic Processes; Intracranial Hemorrhages; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Nervous System Diseases; Cerebrovascular Disorders; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: HX-A-2024009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data and study materials will be accessible.
• IPD Sharing Time Frame: After publication of the main trial results, subject to legal and ethical approvals.
• IPD Sharing Access Criteria: Approved investigators will have access to deidentified data by contacting the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No