Intracranial HemorrhagesSERIC-sICHNCT03484936
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
A study testing Remote ischemic conditioning in people with Intracranial Hemorrhages, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 530 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 15 Jun 2027
- 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 ≥ 18 years
- Supratentorial intracerebral hemorrhage confirmed by brain CT scan
- Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
- NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
- Able to commence RIC treatment within 12 hours of stroke onset
- Signed and dated informed consent is obtained.
Who cannot join
- Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
- A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- Already booked for surgical treatment
- Life expectancy of less than 90 days due to comorbid conditions
- Severe hematologic disease
- Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
Show all 15Show fewer
- Concurrent use of glibenclamide or nicorandil
- Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC
- Severe hepatic and renal dysfunction
- Platelet count <100×10^9/L
- Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
- Known pregnancy, or positive pregnancy test, or breastfeeding
- Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
- A high likelihood that the patient will not adhere to the study treatment and follow up regimen
- Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhenni Guo, MD contact
China1 site
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, doctor_yangyi@163.com
About this study
The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
Read the detailed description
Intracerebral hemorrhage is a devastating disease with a high rate of severe disability and death, while no specific treatment has been proven to improve functional outcome. As a result, new approaches need to be developed to treat intracerebral hemorrhage. Animal and human trials showed treatment with remote ischemic conditioning was safe for intracerebral hemorrhage. And repetitive remote ischemic conditioning has been shown to improve sensorimotor and neuropathological outcomes following experimental hemorrhagic stroke. Therefore, we hypothesize that repetitive remote ischemic conditioning could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled double-blind trial to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
- Conditions
- Intracranial Hemorrhages
- Being tested
- Remote ischemic conditioning, Sham remote ischemic conditioning
- Keywords
- Intracranial Hemorrhages, remote ischemic conditioning
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Also called RIC
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days.
Sham remote ischemic conditioningProcedure or surgery
Also called Sham RIC
Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| RIC+Standard medical treatment | Active comparator | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage. Receives: Procedure: Remote ischemic conditioning |
| Sham RIC+Standard medical treatment | Placebo comparator | Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage. Receives: Procedure: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.
Measured: 3 months
Secondary outcomes (1)
Frequency of adverse events
The safety endpoints will include all adverse events until day-7 or discharge (whichever is earlier), and severe adverse events through day-90 after the onset of intracerebral hemorrhage.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start15 Mar 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- 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
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, MD, PhD, Study chair, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484936
- Sponsor's protocol ID
- SERIC-sICH
- Acronym
- SERIC-sICH
- Status last verified
- Feb 2024
- First submitted
- 25 Mar 2018
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT03484936
- Acronym / sponsor ID
- SERIC-sICH / SERIC-sICH
- Conditions
- Intracranial Hemorrhages
- Keywords
- Intracranial Hemorrhages, remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 2 Apr 2018 (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.
The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
Detailed description
Intracerebral hemorrhage is a devastating disease with a high rate of severe disability and death, while no specific treatment has been proven to improve functional outcome. As a result, new approaches need to be developed to treat intracerebral hemorrhage. Animal and human trials showed treatment with remote ischemic conditioning was safe for intracerebral hemorrhage. And repetitive remote ischemic conditioning has been shown to improve sensorimotor and neuropathological outcomes following experimental hemorrhagic stroke. Therefore, we hypothesize that repetitive remote ischemic conditioning could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled double-blind trial to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
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 |
|---|---|---|
| RIC+Standard medical treatment | Active comparator | Procedure: Remote ischemic conditioningRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days. Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage. |
| Sham RIC+Standard medical treatment | Placebo comparator | Procedure: Sham remote ischemic conditioningSham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Supratentorial intracerebral hemorrhage confirmed by brain CT scan
- Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
- NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
- Able to commence RIC treatment within 12 hours of stroke onset
Key exclusion criteria (15 listed)
- Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
- A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- Already booked for surgical treatment
- Life expectancy of less than 90 days due to comorbid conditions
- Severe hematologic disease
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 conditioningAlso: RICRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days. | Procedure or surgery | RIC+Standard medical treatment |
| Sham remote ischemic conditioningAlso: Sham RICSham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days. | Procedure or surgery | Sham RIC+Standard medical treatment |
Primary outcome
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
Time frame: 3 months
The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.
1 secondary outcome
Frequency of adverse events
Time frame: 3 months
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 2 Oct 2024.
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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.
Zhenni Guo, MD contact
Yi Yang, MD, PhD study chair
Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
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 in people with Intracranial Hemorrhages, run by Yi Yang 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 15 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 2 Oct 2024. 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 Yi Yang, MD, PhD (0086-13756661217, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 (time frame: 3 months). 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 2 Oct 2024.