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Clinical Trials in China / NCT06819657
Recruiting Not applicable

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

NCT06819657 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Not applicable
Started
2025-03-10
Last updated
2025-09-09

Condition(s) studied

Subarachnoid Hemorrhage, AneurysmalCerebrovascular DisordersBrain DiseasesStrokeCardiovascular DiseasesVascular DiseasesNervous System Diseases

Investigational drug(s) / intervention(s)

Remote Ischemic Conditioning Treatment InstrumentGuideline-based therapy

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

Guideline-based therapy: Guideline-based therapy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of mRS (0-2) — 90±7 days post-enrollment in the study
    Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
  • incidence rate of RIC adverse events — 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.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tiantan Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819657 on ClinicalTrials.gov ↗ ← All trials in China