Subarachnoid HemorrhageREPAIRNCT06711302
Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage
A study testing Remote Ischemic Conditioning treatment instrument in people with Subarachnoid Hemorrhage and Cerebrovascular Disorders, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebrovascular Disorders, Brain Diseases
- What is being tested?
- Remote Ischemic Conditioning treatment instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Apr 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aneurysmal subarachnoid hemorrhage confirmed by imaging examination (diagnosed by computed tomography and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography);
- The Hunt-Hess grade is 2-3 at admission;
- Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;
- The responsible aneurysm has been treated by endovascular interventional therapy;
- 18≤ age ≤80 years old;
- Informed consent must be obtained from participants or legally authorized representatives.
Who cannot join
- Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;
- Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;
- With severe comorbidities and a life expectancy of less than 90 days;
- Refractory hypertension (Systolic blood pressure> 180 mmHg or diastolic blood pressure >110 mmHg);
- Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;
- Concurrent participation in another protocol investigating a different experimental therapy;
- Any condition that the investigator believes may increase the patient's risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital
Beijing
Aihua Liu, Doctor, +15901398688, liuaihuadoctor@ccmu.edu.cn
About this study
Official title: Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage: a Multi-center, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH.
Remote ischemic conditioning(RIC) has gained considerable attention in the treatment of stroke, particularly ischemic stroke, with numerous studies demonstrating its potential to enhance neurological outcomes compared to conventional treatments alone.RIC for the treatment of SAH is an investigative strategy in its initial stages. The neuroprotective effects of RIC, particularly its potential to preserve cranial nerve function and ameliorate neurological deficits, confer significant value in the treatment of SAH patients.
Read more
The precise manner in which SAH patients may benefit from RIC treatment, and the mechanisms by which it improves neurological function, remain to be fully understood. Consequently, randomized controlled trials are necessary to validate the efficacy of RIC in this patient population and to delineate the optimal therapeutic protocols for its application.
Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of SAH.
- Conditions
- Subarachnoid Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Stroke, Cardiovascular Diseases, Vascular Diseases
- Being tested
- Sham RIC, Remote Ischemic Conditioning treatment instrument
- Medical subject headings
- Subarachnoid Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Stroke, Cardiovascular Diseases, Vascular Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham RICDevice
Remote Ischemic Conditioning is given twice a day with 60mmHg pressure.
Remote Ischemic Conditioning treatment instrumentDevice
Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.
| Study group | Role | What they receive |
|---|---|---|
| Sham group | Sham comparator | Guideline-based therapy+Sham RIC is given twice a day with 60mmHg pressure. Receives: Device: Sham RIC |
| RIC Group | Experimental | Guideline-based therapy+RIC RIC is given twice a day with 200mmHg pressure. Receives: Device: Remote Ischemic Conditioning treatment instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mRS (0-2)
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
Measured: 90±7 days
Secondary outcomes (5)
Proportion of mRS (0-1)
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
Measured: 90±7 days
mRS Score as ordinal variable
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
Measured: 7±1 days
mRS Score as ordinal variable
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
Measured: 30±7 days
Cognitive function score as ordinal variable
Montreal Cognitive Assessment, MoCA. The total score is 30, with higher scores indicating better cognitive function.
Measured: 7±1 days
The complete blood count
up to 30 days
Measured: During hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711302
- Sponsor's protocol ID
- HX-A-2024009
- Acronym
- REPAIR
- Status last verified
- Jul 2025
- First submitted
- 25 Nov 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data and study materials will be accessible.
Publications
Jin T, Niu H, Liu L, Yin Y, Zhao W, Feng X, Xu L, Hess DC, Liu A, Ji X. Remote ischaemic conditioning for efficacy in patients with aneurysmal subarachnoid haemorrhage (REPAIR): protocol for a multicentre, randomised, double-blind, sham-controlled, parallel-group trial. BMJ Open. 2025 Aug 11;15(8):e101350. doi: 10.1136/bmjopen-2025-101350.
PubMed 40789732
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning for Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage: a Multi-center, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
- ClinicalTrials.gov ID
- NCT06711302
- Acronym / sponsor ID
- REPAIR / HX-A-2024009
- Conditions
- Subarachnoid Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Stroke, Cardiovascular Diseases, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Dec 2024 (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.
Several recent large-scale clinical trials aimed at improving subarachnoid hemorrhage(SAH) outcomes have concluded with negative results, failing to enhance the prognosis for these patients. Consequently, there is an urgent demand for novel treatment strategies and approaches to address the challenges posed by SAH.
Remote ischemic conditioning(RIC) has gained considerable attention in the treatment of stroke, particularly ischemic stroke, with numerous studies demonstrating its potential to enhance neurological outcomes compared to conventional treatments alone.RIC for the treatment of SAH is an investigative strategy in its initial stages. The neuroprotective effects of RIC, particularly its potential to preserve cranial nerve function and ameliorate neurological deficits, confer significant value in the treatment of SAH patients.
The precise manner in which SAH patients may benefit from RIC treatment, and the mechanisms by which it improves neurological function, remain to be fully understood. Consequently, randomized controlled trials are necessary to validate the efficacy of RIC in this patient population and to delineate the optimal therapeutic protocols for its application.
Based on the above discussion, this study aims to explore the efficacy and safety of RIC in the treatment of SAH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham group | Sham comparator | Device: Sham RICGuideline-based therapy+Sham RIC is given twice a day with 60mmHg pressure. |
| RIC Group | Experimental | Device: Remote Ischemic Conditioning treatment instrumentGuideline-based therapy+RIC RIC is given twice a day with 200mmHg pressure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with aneurysmal subarachnoid hemorrhage confirmed by imaging examination (diagnosed by computed tomography and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography);
- The Hunt-Hess grade is 2-3 at admission;
- Onset of aneurysmal subarachnoid hemorrhage ≤72 hours;
- The responsible aneurysm has been treated by endovascular interventional therapy;
- 18≤ age ≤80 years old;
Key exclusion criteria (7 listed)
- Patients with other intracerebral hemorrhage or other types of subarachnoid hemorrhage;
- Previous neurological deficits (mRS Score ≥1) or psychiatric disorders that can confound neurological or functional assessments;
- With severe comorbidities and a life expectancy of less than 90 days;
- Refractory hypertension (Systolic blood pressure> 180 mmHg or diastolic blood pressure >110 mmHg);
- Contraindications of RIC: severe soft tissue injury of the lower limbs, etc;
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 |
|---|---|---|
| Sham RICRemote Ischemic Conditioning is given twice a day with 60mmHg pressure. | Device | Sham group |
| Remote Ischemic Conditioning treatment instrumentRemote Ischemic Conditioning is given twice a day with 200mmHg pressure. | Device | RIC Group |
Primary outcome
Proportion of mRS (0-2)
Time frame: 90±7 days
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
5 secondary outcomes
Proportion of mRS (0-1)
Time frame: 90±7 days
mRS Score as ordinal variable
Time frame: 7±1 days
mRS Score as ordinal variable
Time frame: 30±7 days
Cognitive function score as ordinal variable
Time frame: 7±1 days
The complete blood count
Time frame: During hospitalization
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 10 Jul 2025.
- Derived from this study: PubMed 40789732Jin T, Niu H, Liu L, Yin Y, Zhao W, Feng X, Xu L, Hess DC, Liu A, Ji X. Remote ischaemic conditioning for efficacy in patients with aneurysmal subarachnoid haemorrhage (REPAIR): protocol for a multicentre, randomised, double-blind, sham-controlled, parallel-group trial. BMJ Open. 2025 Aug 11;15(8):e101350. doi: 10.1136/bmjopen-2025-101350.
- Individual participant dataSharing planned: Yes. De-identified participant data and study materials will be accessible.
Related trials for Subarachnoid Hemorrhage
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RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
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Not yet recruiting
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning treatment instrument in people with Subarachnoid Hemorrhage and Cerebrovascular Disorders, run by Beijing Tiantan Hospital at 1 site in China.
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 6 inclusion and 7 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Aihua Liu, Doctor (+8615901398688, liuaihuadoctor@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mRS (0-2) (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711302, which also lists 1 linked publication.
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 10 Jul 2025.