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NCT Number: NCT06711302

Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage

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.

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sham RIC

Device

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

Remote Ischemic Conditioning treatment instrument

Device

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

Primary outcomes

  1. Proportion of mRS (0-2)

    Time frame: 90±7 days

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

Secondary outcomes

  1. Proportion of mRS (0-1)

    Time frame: 90±7 days

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

  2. mRS Score as ordinal variable

    Time frame: 7±1 days

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

  3. mRS Score as ordinal variable

    Time frame: 30±7 days

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

  4. Cognitive function score as ordinal variable

    Time frame: 7±1 days

    Montreal Cognitive Assessment, MoCA. The total score is 30, with higher scores indicating better cognitive function.

  5. The complete blood count

    Time frame: During hospitalization

    up to 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Aihua Liu, Doctor

CONTACT

[email protected]

+8615901398688

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: REPAIR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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