An interventional study of Remote Ischemic Preconditioning and Sham Ischemic Preconditioning in Aneurysmal Subarachnoid Hemorrhage, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Procedure: Remote Ischemic Preconditioning
Procedure: Sham 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.
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.
Neurological Functional Outcome at 3 Months (mRS)
Assessment of neurological disability and dependency using the modified Rankin Scale (mRS) performed by a blinded neurologist. The mRS is a 6-point scale (0 to 5), with 5 being a severe disability.
Time frame: 3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage
Evaluation of mortality at 3 Months
Comparison of all-cause mortality between the RIPC group and the sham group
Time frame: From day 0 to 3 months post-hemorrhage
Long-term Neurological Outcome at 12 Months (mRS)
Assessment of long-term neurological disability and dependency using the modified Rankin Scale (mRS) performed by a blinded neurologist. The mRS is a 6-point scale (0 to 5), with 5 being a severe disability.
Time frame: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
Evaluation of Cognitive Function at 12 months (MMSE)
Evaluation of cognitive performance assessed using the Mini-Mental State Examination (MMSE). The MMSE score ranks from 0 to 30, with 30 being a normal congnitive performance and 0 serious cognitive impairments.
Time frame: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
Evaluation of Cognitive Function at 12 months (MoCA)
Evaluation of cognitive performance assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is scored out of 30 points, with high scores suggesting mild or no cognitive impairments, and low scores severe cognitive impairments.
Time frame: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
Safety Outcomes
Incidence, nature, and severity of adverse events and serious adverse events occurring during the study period.
Time frame: From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
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Centre Hospitalier Universitaire de Nice