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Not yet recruiting NCT06711302

Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage

No phase Interventional Subarachnoid Hemorrhage Cerebrovascular Disorders Brain Diseases Stroke

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: Sham RIC, Remote Ischemic Conditioning treatment instrument.
Who it may be relevant to
Registry conditions: Subarachnoid Hemorrhage, 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 Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage: a Multi-center, Randomized, Double-blind, Sham-controlled, Parallel-group Trial

Overview

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.

Interventions

  • Device Sham RIC
    Remote Ischemic Conditioning is given twice a day with 60mmHg pressure.
  • Device Remote Ischemic Conditioning treatment instrument
    Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.

Primary outcome measures

  • Proportion of mRS (0-2) [Time frame: 90±7 days]
Secondary outcome measures (5)
  • Proportion of mRS (0-1) [Time frame: 90±7 days]
  • mRS Score as ordinal variable [Time frame: 7±1 days]
  • mRS Score as ordinal variable [Time frame: 30±7 days]
  • Cognitive function score as ordinal variable [Time frame: 7±1 days]
  • The complete blood count [Time frame: During hospitalization]

Eligibility criteria

Inclusion criteria

  • 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;
  • 18≤ age ≤80 years old;
  • Informed consent must be obtained from participants or legally authorized representatives.

Exclusion criteria

  • 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.

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
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Publications

  • 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

Identifiers

NCT: NCT06711302 · HX-A-2024009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗