Prevention of Ischemia in Aneurysmal Subarachnoid Hemorrhage Through Remote Ischemic Preconditioning

NCT07761520 | Not Yet Recruiting

• 1 other identifier: 24-AOI-04
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

Aneurysmal Subarachnoid Hemorrhage (aSAH); Remote Ischemic Preconditioning (RIPC)

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage

Secondary Outcomes (5)

• Evaluation of mortality at 3 Months

  From day 0 to 3 months post-hemorrhage

• Long-term Neurological Outcome at 12 Months (mRS)

  12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage

• Evaluation of Cognitive Function at 12 months (MMSE)

  12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage

• Evaluation of Cognitive Function at 12 months (MoCA)

  12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage

• Safety Outcomes

  From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.

Study Arms (2)

Ischemic Preconditioning (RIPC)

EXPERIMENTAL

Procedure: Remote Ischemic Preconditioning

Sham Procedure

PLACEBO COMPARATOR

Procedure: Sham Ischemic Preconditioning

Interventions

Remote Ischemic Preconditioning PROCEDURE

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.

Ischemic Preconditioning (RIPC)

Sham Ischemic Preconditioning PROCEDURE

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.

Sham Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Hospitalization for aneurysmal subarachnoid hemorrhage confirmed by CT scan and/or lumbar puncture
• Confirmation of intracranial aneurysm by CT angiography and/or cerebral angiography
• Written informed consent obtained from the patient or legal representative
• Affiliation to a social security system

You may not qualify if:

• Skin, orthopedic, or vascular conditions of the limbs contraindicating ischemic preconditioning (e.g., ulcers, fractures, deep vein thrombosis)
• Pregnancy
• Withdrawal of informed consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jacques Sedat, MD

CONTACT

+33 4 92 03 38 07; sedat.j@chu-nice.fr

Eve Ledoux

CONTACT

+33 4 92 03 27 29; ledoux.e@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08