Clinical trial NCT06711302: Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage
Official title: Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage: a Multi-center, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subarachnoid Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Stroke
Cardiovascular Diseases
Vascular Diseases
Nervous System Diseases
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 500
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: Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH.

Remote ischemic conditioning(RIC) has gained considerable attention in the treatment of stroke, particularly ischemic stroke, with numerous studies demonstrating its potential to enhance neurological outcomes compared to conventional treatments alone.RIC for the treatment of SAH is an investigative strategy in its initial stages. The neuroprotective effects of RIC, particularly its potential to preserve cranial nerve function and ameliorate neurological deficits, confer significant value in the treatment of SAH patients.

The precise manner in which SAH patients may benefit from RIC treatment, and the mechanisms by which it improves neurological function, remain to be fully understood. Consequently, randomized controlled trials are necessary to validate the efficacy of RIC in this patient population and to delineate the optimal therapeutic protocols for its application.

Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of SAH.


Eligibility criteria: Inclusion Criteria:

1. Patients with aneurysmal subarachnoid hemorrhage confirmed by imaging examination (diagnosed by computed tomography and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography);
2. The Hunt-Hess grade is 2-3 at admission;
3. Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;
4. The responsible aneurysm has been treated by endovascular interventional therapy;
5. 18≤ age ≤80 years old;
6. Informed consent must be obtained from participants or legally authorized representatives.

Exclusion Criteria:

1. Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;
2. Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;
3. With severe comorbidities and a life expectancy of less than 90 days;
4. Refractory hypertension (Systolic blood pressure\> 180 mmHg or diastolic blood pressure \>110 mmHg);
5. Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;
6. Concurrent participation in another protocol investigating 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
Secondary outcomes:
measure: Proportion of mRS (0-1)
timeFrame: 90±7 days
measure: mRS Score as ordinal variable
timeFrame: 7±1 days
measure: mRS Score as ordinal variable
timeFrame: 30±7 days
measure: Cognitive function score as ordinal variable
timeFrame: 7±1 days
measure: The complete blood count
timeFrame: During hospitalization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: