RecruitingNot ApplicableNCT06819657

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

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


Sponsor

Beijing Tiantan Hospital

Enrollment

40 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • Imaging examination confirmed aneurysmal subarachnoid hemorrhage.
  • Responsible aneurysms received craniotomy clipping within 24 hours.
  • ≤ age ≤80 years old.
  • Informed consent of the participant or legally authorized representative

Exclusion Criteria7

  • 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.

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Interventions

DEVICERemote 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

OTHERGuideline-based therapy

Guideline-based therapy


Locations(1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

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NCT06819657


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