Prevention of Ischemia in Aneurysmal Subarachnoid Hemorrhage Through Remote Ischemic Preconditioning (HMA)
Remote Ischemic Preconditioning (RIPC) and Aneurysmal Subarachnoid Hemorrhage (SAH)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacques Sedat, MD
- Phone Number: +33 4 92 03 38 07
- Email: sedat.j@chu-nice.fr
Study Contact Backup
- Name: Eve Ledoux
- Phone Number: +33 4 92 03 27 29
- Email: ledoux.e@chu-nice.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ischemic Preconditioning (RIPC)
|
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.
|
|
Placebo Comparator: Sham 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of mortality at 3 Months
Time Frame: From day 0 to 3 months post-hemorrhage
|
Comparison of all-cause mortality between the RIPC group and the sham group
|
From day 0 to 3 months post-hemorrhage
|
|
Long-term Neurological Outcome at 12 Months (mRS)
Time Frame: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
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.
|
12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
|
Evaluation of Cognitive Function at 12 months (MMSE)
Time Frame: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
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.
|
12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
|
Evaluation of Cognitive Function at 12 months (MoCA)
Time Frame: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
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.
|
12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
|
|
Safety Outcomes
Time Frame: From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
|
Incidence, nature, and severity of adverse events and serious adverse events occurring during the study period.
|
From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-AOI-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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