Clinical trial NCT06819657: Safety and Efficacy of Remote Ischemic Preconditioning in Patients with Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping
Official title: Safety and Efficacy of Remote Ischemic Preconditioning in Patients with Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping：a Multi-center, Randomized, Open-label, Evaluator-blind, Sham-controlled, Parallel-group Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Cerebrovascular Disorders
Brain Diseases
Stroke
Cardiovascular Diseases
Vascular Diseases
Nervous System Diseases
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the safety and efficacy of remote ischemic regulation (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) undergoing craniotomy.

Aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when an aneurysm ruptures in the brain causing bleeding in the Subarachnoid space. Cerebral aneurysm clipping are usually needed to stop the bleeding and stabilize the patient's condition.

Remote Ischemic regulation (RIC) is a non-invasive treatment that uses a blood pressure cuff to temporarily block and restore blood flow to the arm or leg. Research suggests that this process may help protect the brain and improve recovery from brain injury or surgery. Although RIC has shown potential to improve outcomes in patients with other types of brain injury, its effect on patients with aSAH who undergo cerebral aneurysm clipping is unclear.

This study will evaluate whether RIC can reduce complications, improve brain function, and enhance overall recovery in patients. The findings will help determine whether RIC should be included in the standard treatment regimen for patients with aSAH.


Eligibility criteria: 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 outcomes:
measure: Proportion of mRS (0-2)
timeFrame: 90±7 days post-enrollment in the study
Secondary outcomes:
measure: Proportion of mRS (0-1)
timeFrame: 90±7 days post-enrollment in the study
measure: mRS Score as ordinal variable
timeFrame: 7±1 days post-enrollment in the study
measure: mRS Score as ordinal variable
timeFrame: 30±7 days post-enrollment in the study
measure: Cognitive function score as ordinal variable
timeFrame: 7±1 days post-enrollment in the study
measure: The complete blood count
timeFrame: During hospitalization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: