ClinicalTrials.gg
Not yet recruitingNCT03484936SERIC-sICHUpdated Oct 2, 2024

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage

An interventional study of Remote ischemic conditioning and Sham remote ischemic conditioning in Intracranial Hemorrhages, sponsored by Yi Yang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Yi Yang · Not applicable, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 31 studies in Intracranial Hemorrhages with a site in China — 16 open to participants now, 16 under way, none of them phase 3. Intracranial Hemorrhages · China.

Planned enrollment
10th of 22
530 · median 452
Started
2026
with 4 others
No phase
14 of 31
9 open now
Primary completion
2026-09
later than 6 of 15 live
Registered
9th of 31
by date
Lead sponsor
2 of 31
Yi Yang

Among the 31 studies in Intracranial Hemorrhages with a site in China, this one is the 10th largest by planned enrollment of the 22 interventional ones that give a count, is one of 5 that started in 2026, is one of 14 with no phase, reaches primary completion later than 6 of the 15 other live ones, and was the 9th registered.

Intracranial Hemorrhages

211 studies on the registry are indexed under Intracranial Hemorrhages; 62 are open to participants now.

Browse Intracranial Hemorrhages studies →

Open to participants now

16 of the 31 studies in Intracranial Hemorrhages with a site in China are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 43 Intracranial Hemorrhages studies recruiting now, 27 (63%) set no upper age limit and 5 (12%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 31 studies in Intracranial Hemorrhages with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Intracranial Hemorrhages

Keywords

  • Intracranial Hemorrhages
  • remote ischemic conditioning
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years
  2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan
  3. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
  4. NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
  5. Able to commence RIC treatment within 12 hours of stroke onset
  6. Signed and dated is obtained.

Exclusion criteria

Exclusion Criteria:

  1. Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
  2. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
  3. Already booked for surgical treatment
  4. of less than 90 days due to comorbid conditions
  5. Severe hematologic disease
  6. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
  7. Concurrent use of glibenclamide or nicorandil
  8. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a for application of RIC
  9. Severe hepatic and renal dysfunction
  10. count \<100×10\^9/L
  11. Coagulopathy defined as ,APTT,and PT beyond the
  12. Known pregnancy, or positive pregnancy test, or breastfeeding
  13. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
  14. A high likelihood that the patient will not adhere to the study treatment and follow up regimen
  15. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
530 participants (estimated)

Study arms

  • Active comparator
    RIC+Standard medical treatment

    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.

    Procedure: Remote ischemic conditioning

  • Placebo comparator
    Sham RIC+Standard medical treatment

    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.

    Procedure: Sham remote ischemic conditioning

Interventions

  • ProcedureRemote ischemic conditioning

    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.

    Also known as: RIC

  • ProcedureSham remote ischemic conditioning

    Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.

    Also known as: Sham RIC

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 3 months

Other outcomes

  1. Proportion of hematoma growth

    The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage.

    Time frame: 24 hours

  2. Proportion of hematoma absorption

    The proportional change in hematoma volume between 24h and 14 days or discharge (whichever is earlier) after the onset of intracerebral hemorrhage.

    Time frame: 14 days

  3. Changes of hematological indicators

    The changes of hematological indicators (inflammatory cytokine,et al.) during the first 24h and 7 days after the onset of intracerebral hemorrhage.

    Time frame: 24 hours; 7 days

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Sep 2026, 6 months later.

Of 34 interventional studies with no phase under Intracranial Hemorrhages, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 73. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2018
First posted
Apr 2, 2018
StartEst.
Mar 15, 2026
Primary completionEst.
Sep 15, 2026
CompletionEst.
Jun 15, 2027
Last update
Oct 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03484936
Lead sponsor
Yi Yang
Responsible party
Yi Yang (Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Apr 2, 2018
Start date
Mar 15, 2026 (estimated)
Primary completion
Sep 15, 2026 (estimated)
Completion
Jun 15, 2027 (estimated)
Last update
Oct 2, 2024

Study contacts

Yi Yang, MD, PhD
Contact
doctor_yangyi@163.com
0086-13756661217
Zhenni Guo, MD
Contact
zhen1ni2@163.com
Yi Yang, MD, PhD
study chair · Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion