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NOT YET RECRUITING
NCT07761520
NA

Prevention of Ischemia in Aneurysmal Subarachnoid Hemorrhage Through Remote Ischemic Preconditioning

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

Summary

Aneurysmal subarachnoid hemorrhage (SAH) is a severe form of stroke caused by bleeding around the brain. Despite early treatment of the initial hemorrhage, many patients develop delayed cerebral ischemia several days later, which is a major cause of neurological disability, cognitive impairment, and mortality. Current preventive and therapeutic strategies are only partially effective, highlighting the need for new treatment approaches. This study investigates a simple, non-invasive technique called remote ischemic preconditioning (RIPC). RIPC consists of brief, repeated cycles of limb ischemia and reperfusion induced by a blood pressure cuff. RIPC is thought to activate endogenous protective mechanisms that may improve the brain's tolerance to ischemia. Although beneficial effects have been reported in experimental models and cardiovascular diseases, its clinical efficacy in aneurysmal SAH remains uncertain. In this randomized, controlled, single-blinded, multicenter study, adult patients admitted with aneyrysmal SAH will be randomly assigned to receive RIPC or a sham procedure. The RIPC group will undergo cycles of brief lower-limb ischemia using a pressure cuff, while the sham group will receive an identical procedure without inducing ischemia. Patients and neurologists assessing outcomes will remain blinded to group allocation. The intervention will be performed every two days from day 2 to day 10 after hemorrhage. Neurological outcome will be assessed at 3 months using the modified Rankin Scale. Secondary outcomes include mortality at 3 months, long-term neurological and cognitive function outcomes at 12 months, and the incidence of adverse events related to the procedure. If effective, RIPC could become a simple, low-cost, widely accessible method to reduce disability after SAH. The results may help improve future treatment strategies for this severe condition.

Official title: Remote Ischemic Preconditioning (RIPC) and Aneurysmal Subarachnoid Hemorrhage (SAH)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-09

Completion Date

2029-09

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

PROCEDURE

Remote Ischemic Preconditioning

Three cycles of lower-limb ischemia and reperfusion using a blood pressure cuff inflated to 20 mmHg above systolic blood pressure for 5 minutes followed by 5 minutes of reperfusion. The procedure is performed every two days from day 2 to day 10 after aneurysmal subarachnoid hemorrhage.

PROCEDURE

Sham Ischemic Preconditioning

Identical procedure to the experimental arm, except the cuff is inflated to only 30 mmHg, insufficient to induce ischemia, giving the sensation of pressure without therapeutic effect. Performed every two days from day 2 to day 10 post-hemorrhage.