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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of hematoma growth | The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage. | 24 hours |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang, MD, PhD | Contact | 0086-13756661217 | doctor_yangyi@163.com | |
| Zhenni Guo, MD | Contact | zhen1ni2@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Yang, MD, PhD | Neuroscience Center, Department of Neurology, The First Hospital of Jilin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham remote ischemic conditioning | Procedure | Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days. |
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| 14 days |
| 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. | 24 hours; 7 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |