Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage (REPAIR)

Capital Medical University

Status: Not yet enrolling

Conditions: Subarachnoid Hemorrhage; Stroke; Nervous System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases

Treatments: Device: Sham RIC; Device: Remote Ischemic Conditioning treatment instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT06711302

HX-A-2024009

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups

Sham group

Sham Comparator group

Description:

Guideline-based therapy+Sham RIC is given twice a day with 60mmHg pressure.

Treatment:

Device: Sham RIC

RIC Group

Experimental group

Description:

Guideline-based therapy+RIC RIC is given twice a day with 200mmHg pressure.

Treatment:

Device: Remote Ischemic Conditioning treatment instrument