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Clinical Trials/NCT07761520
NCT07761520Not yet recruitingNot Applicable

Remote Ischemic Preconditioning (RIPC) and Aneurysmal Subarachnoid Hemorrhage (SAH)

Centre Hospitalier Universitaire de Nice0 sites140 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
140
Primary Endpoint
Neurological Functional Outcome at 3 Months (mRS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

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

Arms & Interventions

Ischemic Preconditioning (RIPC)

Experimental

Intervention: Remote Ischemic Preconditioning (Procedure)

Sham Procedure

Placebo Comparator

Intervention: Sham Ischemic Preconditioning (Procedure)

Outcomes

Primary Outcomes

Neurological Functional Outcome at 3 Months (mRS)

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

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.

Secondary Outcomes

  • Safety Outcomes(From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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