SERIC-sICH: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
Other Names:
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| 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
Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [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.
Secondary Outcome Measures
- Frequency of adverse events [3 months]
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.
Other Outcome Measures
- Proportion of hematoma growth [24 hours]
The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage.
- Proportion of hematoma absorption [14 days]
The proportional change in hematoma volume between 24h and 14 days or discharge (whichever is earlier) after the onset of intracerebral hemorrhage.
- Changes of hematological indicators [24 hours; 7 days]
The changes of hematological indicators (inflammatory cytokine,et al.) during the first 24h and 7 days after the onset of intracerebral hemorrhage.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Supratentorial intracerebral hemorrhage confirmed by brain CT scan
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Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
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NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
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Able to commence RIC treatment within 12 hours of stroke onset
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Signed and dated informed consent is obtained.
Exclusion Criteria:
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Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
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A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
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Already booked for surgical treatment
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Life expectancy of less than 90 days due to comorbid conditions
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Severe hematologic disease
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Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
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Concurrent use of glibenclamide or nicorandil
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Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC
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Severe hepatic and renal dysfunction
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Platelet count <100×10^9/L
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Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
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Known pregnancy, or positive pregnancy test, or breastfeeding
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Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
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A high likelihood that the patient will not adhere to the study treatment and follow up regimen
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Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Hospital of Jilin University | Changchun | Jilin | China | 130000 |
Sponsors and Collaborators
- Yi Yang
Investigators
- Study Chair: Yi Yang, MD, PhD, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SERIC-sICH