Subarachnoid Hemorrhage, Aneurysmal, Cerebrovascular Disorders, Brain Diseases, Stroke, Cardiovascular Diseases, Vascular Diseases, Nervous System Diseases
Conditions
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.
Interventions
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
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRS Score as ordinal variable | 7±1 days post-enrollment in the study | Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis. |
| incidence rate of aSAH complications | From enrollment to 90 days post-enrollment | The complications of aneurysmal subarachnoid hemorrhage mainly include cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, rebleeding, etc. |
Countries
China
Contacts
Primary ContactAihua Liu, Doctor
Outcome results
None listed