Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Ischemic Conditioning Treatment Instrument, Guideline-based therapy.
- Who it may be relevant to
- Registry conditions: Subarachnoid Hemorrhage, Aneurysmal, Cerebrovascular Disorders, Brain Diseases, Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 - Other Guideline-based therapy
Guideline-based therapy
Primary outcome measures
- Proportion of mRS (0-2) [Time frame: 90±7 days post-enrollment in the study]
- incidence rate of RIC adverse events [Time frame: From enrollment to the end of RIC at 1 week]
Secondary outcome measures (3)
- mRS Score as ordinal variable [Time frame: 7±1 days post-enrollment in the study]
- mRS Score as ordinal variable [Time frame: 30±7 days post-enrollment in the study]
- incidence rate of aSAH complications [Time frame: From enrollment to 90 days post-enrollment]
Eligibility criteria
Inclusion criteria
- Imaging examination confirmed aneurysmal subarachnoid hemorrhage.
- Responsible aneurysms received craniotomy clipping within 24 hours.
- 18≤ age ≤80 years old.
- Informed consent of the participant or legally authorized representative
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Publications
- 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
Identifiers
NCT: NCT06819657 · HX-B-2024033