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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Proportion of mRS (0-2)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
control group
Guideline-based therapy
Intervention: Guideline-based therapy (Other)
RIC Group
Guideline-based therapy + RIC (200 mmHg, bid, 7d)
Intervention: Remote Ischemic Conditioning Treatment Instrument (Device)
RIC Group
Guideline-based therapy + RIC (200 mmHg, bid, 7d)
Intervention: Guideline-based therapy (Other)
Outcomes
Primary Outcomes
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.
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.
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
- mRS Score as ordinal variable(30±7 days post-enrollment in the study)
- incidence rate of aSAH complications(From enrollment to 90 days post-enrollment)
- mRS Score as ordinal variable(30±7 days post-enrollment in the study)
- mRS Score as ordinal variable(7±1 days post-enrollment in the study)