Subarachnoid Hemorrhage, AneurysmalNCT06819657
Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping
A study testing Remote Ischemic Conditioning Treatment Instrument and Guideline-based therapy in people with Subarachnoid Hemorrhage, Aneurysmal and Cerebrovascular Disorders, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study was designed to evaluate the safety and efficacy of remote ischemic conditioning (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) following surgical clipping. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Cerebrovascular Disorders, Brain Diseases
- What is being tested?
- Remote Ischemic Conditioning Treatment Instrument and Guideline-based therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 30 Mar 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
- Imaging examination confirmed aneurysmal subarachnoid hemorrhage.
- Responsible aneurysms received craniotomy clipping within 24 hours.
- 18≤ age ≤80 years old.
- Informed consent of the participant or legally authorized representative
Who cannot join
- Patients with other types of cerebral hemorrhage.
- Prior neurological impairment (mRS Score >1) or mental illness may confuse neurological or functional assessment.
- Severe comorbidities with a life expectancy of less than 90 days.
- Refractory hypertension (systolic blood pressure 180>mmHg or diastolic blood pressure 110>mmHg).
- RIC contraindications: severe soft tissue injury of lower limbs.
- Simultaneously participate in another research program to study 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, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100000
Aihua Liu, Doctor, +8615901398688, liuaihuadoctor@ccmu.edu.cn
About this study
Official title: Remote Ischemic Conditioning for Safety, Feasibility, and Preliminary Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping: An Open-Label, Evaluator-Blinded Randomized Controlled Trial
This study was designed to evaluate the safety and efficacy of remote ischemic conditioning (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) following surgical clipping.
Aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when a cerebral aneurysm ruptures, causing bleeding into the subarachnoid space. Surgical clipping of the aneurysm is a standard procedure used to stop the bleeding and prevent re-rupture, thereby stabilizing the patient's condition.
Read more
Remote ischemic conditioning (RIC) is a non-invasive treatment that involves using a blood pressure cuff to induce brief, temporary cycles of ischemia and reperfusion in a limb. Research suggests that this process may confer systemic protective effects, potentially improving recovery from brain injury or surgery. Although RIC has shown potential to improve outcomes in patients with other neurological conditions, its effect on patients with aSAH who undergo surgical clipping remains unclear.
This study will evaluate whether RIC can reduce complications, improve neurological function, and enhance overall recovery in these patients. The findings will help determine whether RIC should be incorporated into the standard treatment regimen for aSAH.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal, Cerebrovascular Disorders, Brain Diseases, Stroke, Cardiovascular Diseases, Vascular Diseases
- Being tested
- Remote Ischemic Conditioning Treatment Instrument, Guideline-based therapy
- 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.
Remote Ischemic Conditioning Treatment InstrumentDevice
Remote ischemic conditioning (RIC) was administered twice daily to the unilateral lower limb using a blood pressure cuff inflated to 200 mmHg for 7 consecutive days post-clipping
Guideline-based therapyOther
Guideline-based therapy
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Guideline-based therapy Receives: Other: Guideline-based therapy |
| RIC Group | Experimental | Guideline-based therapy + RIC (200 mmHg, bid, 7d) Receives: Device: Remote Ischemic Conditioning Treatment Instrument; Other: Guideline-based therapy |
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 post-enrollment in the study
incidence rate of RIC adverse events
RIC adverse events mainly include: limb pain, skin damage, deep vein thrombosis, transient hypertension, etc.
Measured: From enrollment to the end of RIC at 1 week
Secondary outcomes (3)
mRS Score as ordinal variable
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
Measured: 7±1 days post-enrollment in the study
mRS Score as ordinal variable
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
Measured: 30±7 days post-enrollment in the study
incidence rate of aSAH complications
The complications of aneurysmal subarachnoid hemorrhage mainly include cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, rebleeding, etc.
Measured: From enrollment to 90 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start10 Mar 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 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 Hemorrhage, AneurysmalStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT06819657
- Sponsor's protocol ID
- HX-B-2024033
- Status last verified
- Aug 2025
- First submitted
- 5 Feb 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu L, Jin T, Niu H, Yin Y, Yan K, Guan H, Liu A. Remote ischemic conditioning for safety, feasibility and preliminary efficacy of patients with aneurysmal subarachnoid hemorrhage after aneurysm clipping, design, and protocol for an open-label, evaluator blinding randomized controlled trial. Front Neurol. 2025 Nov 20;16:1650773. doi: 10.3389/fneur.2025.1650773. eCollection 2025.
PubMed 41356238
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning for Safety, Feasibility, and Preliminary Efficacy in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping: An Open-Label, Evaluator-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06819657
- Acronym / sponsor ID
- HX-B-2024033
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal, Cerebrovascular Disorders, Brain Diseases, Stroke, Cardiovascular Diseases, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 11 Feb 2025 (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.
This study was designed to evaluate the safety and efficacy of remote ischemic conditioning (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) following surgical clipping.
Aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when a cerebral aneurysm ruptures, causing bleeding into the subarachnoid space. Surgical clipping of the aneurysm is a standard procedure used to stop the bleeding and prevent re-rupture, thereby stabilizing the patient's condition.
Remote ischemic conditioning (RIC) is a non-invasive treatment that involves using a blood pressure cuff to induce brief, temporary cycles of ischemia and reperfusion in a limb. Research suggests that this process may confer systemic protective effects, potentially improving recovery from brain injury or surgery. Although RIC has shown potential to improve outcomes in patients with other neurological conditions, its effect on patients with aSAH who undergo surgical clipping remains unclear.
This study will evaluate whether RIC can reduce complications, improve neurological function, and enhance overall recovery in these patients. The findings will help determine whether RIC should be incorporated into the standard treatment regimen for aSAH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Guideline-based therapyGuideline-based therapy |
| RIC Group | Experimental | Device: Remote Ischemic Conditioning Treatment Instrument, Other: Guideline-based therapyGuideline-based therapy + RIC (200 mmHg, bid, 7d) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Imaging examination confirmed aneurysmal subarachnoid hemorrhage.
- Responsible aneurysms received craniotomy clipping within 24 hours.
- 18≤ age ≤80 years old.
- Informed consent of the participant or legally authorized representative
Key exclusion criteria (7 listed)
- Patients with other types of cerebral hemorrhage.
- Prior neurological impairment (mRS Score >1) or mental illness may confuse neurological or functional assessment.
- Severe comorbidities with a life expectancy of less than 90 days.
- Refractory hypertension (systolic blood pressure 180>mmHg or diastolic blood pressure 110>mmHg).
- RIC contraindications: severe soft tissue injury of lower limbs.
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 Conditioning Treatment InstrumentRemote ischemic conditioning (RIC) was administered twice daily to the unilateral lower limb using a blood pressure cuff inflated to 200 mmHg for 7 consecutive days post-clipping | Device | RIC Group |
| Guideline-based therapyGuideline-based therapy | Other | RIC Group, control group |
Primary outcome
Proportion of mRS (0-2)
Time frame: 90±7 days post-enrollment in the study
Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.
incidence rate of RIC adverse events
Time frame: From enrollment to the end of RIC at 1 week
RIC adverse events mainly include: limb pain, skin damage, deep vein thrombosis, transient hypertension, etc.
3 secondary outcomes
mRS Score as ordinal variable
Time frame: 7±1 days post-enrollment in the study
mRS Score as ordinal variable
Time frame: 30±7 days post-enrollment in the study
incidence rate of aSAH complications
Time frame: From enrollment to 90 days post-enrollment
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 9 Sep 2025.
- Derived from this study: PubMed 41356238Xu L, Jin T, Niu H, Yin Y, Yan K, Guan H, Liu A. Remote ischemic conditioning for safety, feasibility and preliminary efficacy of patients with aneurysmal subarachnoid hemorrhage after aneurysm clipping, design, and protocol for an open-label, evaluator blinding randomized controlled trial. Front Neurol. 2025 Nov 20;16:1650773. doi: 10.3389/fneur.2025.1650773. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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 and Guideline-based therapy in people with Subarachnoid Hemorrhage, Aneurysmal 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 4 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: looking for participants now, as of the sponsor's last update on 9 Sep 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. 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 post-enrollment in the study). The study lists 2 primary outcomes in all. 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 NCT06819657, 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 9 Sep 2025.