Aneurysmal Subarachnoid HemorrhageHMANCT07761520
Prevention of Ischemia in Aneurysmal Subarachnoid Hemorrhage Through Remote Ischemic Preconditioning
A study testing Remote Ischemic Preconditioning in people with Aneurysmal Subarachnoid Hemorrhage, run by Centre Hospitalier Universitaire de Nice.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Skin, orthopedic, or vascular conditions of the limbs contraindicating ischemic preconditioning (e.g., ulcers, fractures, deep vein thrombosis)
- Pregnancy
- Withdrawal of informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Remote Ischemic Preconditioning, Sham Ischemic Preconditioning
- Keywords
- Aneurysmal Subarachnoid Hemorrhage (aSAH), Remote Ischemic Preconditioning (RIPC)
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
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.
Sham Ischemic PreconditioningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Preconditioning (RIPC) | Experimental | Not described Receives: Procedure: Remote Ischemic Preconditioning |
| Sham Procedure | Placebo comparator | Not described Receives: Procedure: Sham Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage
Secondary outcomes (5)
Evaluation of mortality at 3 Months
Comparison of all-cause mortality between the RIPC group and the sham group
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761520
- Sponsor's protocol ID
- 24-AOI-04
- Acronym
- HMA
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning (RIPC) and Aneurysmal Subarachnoid Hemorrhage (SAH)
- ClinicalTrials.gov ID
- NCT07761520
- Acronym / sponsor ID
- HMA / 24-AOI-04
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Aneurysmal Subarachnoid Hemorrhage (aSAH), Remote Ischemic Preconditioning (RIPC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Preconditioning (RIPC) | Experimental | Procedure: Remote Ischemic Preconditioning |
| Sham Procedure | Placebo comparator | Procedure: Sham Ischemic Preconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Skin, orthopedic, or vascular conditions of the limbs contraindicating ischemic preconditioning (e.g., ulcers, fractures, deep vein thrombosis)
- Pregnancy
- Withdrawal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic PreconditioningThree 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 or surgery | Ischemic Preconditioning (RIPC) |
| Sham Ischemic PreconditioningIdentical 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. | Procedure or surgery | Sham Procedure |
Primary outcome
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.
5 secondary outcomes
Evaluation of mortality at 3 Months
Time frame: 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
Evaluation of Cognitive Function at 12 months (MMSE)
Time frame: 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
Safety Outcomes
Time frame: From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Preconditioning in people with Aneurysmal Subarachnoid Hemorrhage, run by Centre Hospitalier Universitaire de Nice.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacques Sedat, MD (+33 4 92 03 38 07, sedat.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Functional Outcome at 3 Months (mRS) (time frame: 3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.