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

Remote Ischemic Conditioning for Safety, Feasibility, and Preliminary Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping: An Open-Label, Evaluator-Blinded Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Subarachnoid Hemorrhage, Aneurysmal
• Intervention / Treatment: Other: Guideline-based therapy; Device: Remote Ischemic Conditioning Treatment Instrument

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Aihua Liu, Doctor; Phone Number: +8615901398688; Email: liuaihuadoctor@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; Guideline-based therapy	Other: Guideline-based therapy; Guideline-based therapy
Experimental: RIC Group; Guideline-based therapy + RIC (200 mmHg, bid, 7d)	Other: Guideline-based therapy; Guideline-based therapy; Device: 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

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS Score as ordinal variable	Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.	7±1 days post-enrollment in the study
mRS Score as ordinal variable	Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.	30±7 days post-enrollment in the study
incidence rate of aSAH complications	The complications of aneurysmal subarachnoid hemorrhage mainly include cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, rebleeding, etc.	From enrollment to 90 days post-enrollment

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Stroke; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Nervous System Diseases; Cerebrovascular Disorders; Subarachnoid Hemorrhage
• Other Study ID Numbers: HX-B-2024033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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