Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06819657

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100000, China

Location status: Recruiting

Location contact

Aihua Liu, Doctor

CONTACT

[email protected]

+8615901398688

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Remote Ischemic Conditioning treatment instrument

Device

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

Guideline-based therapy

Other

Guideline-based therapy

Primary outcomes

  1. Proportion of mRS (0-2)

    Time frame: 90±7 days post-enrollment in the study

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

  2. incidence rate of RIC adverse events

    Time frame: From enrollment to the end of RIC at 1 week

    RIC adverse events mainly include: limb pain, skin damage, deep vein thrombosis, transient hypertension, etc.

Secondary outcomes

  1. mRS Score as ordinal variable

    Time frame: 7±1 days post-enrollment in the study

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

  2. mRS Score as ordinal variable

    Time frame: 30±7 days post-enrollment in the study

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

  3. incidence rate of aSAH complications

    Time frame: From enrollment to 90 days post-enrollment

    The complications of aneurysmal subarachnoid hemorrhage mainly include cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, rebleeding, etc.

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Sep 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.