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Intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Currently, ICH has been a devastating type of stroke that lacking effective therapy. Remote ischemic conditioning (RIC), a systematically protective strategy, has been found to have neuroprotective effects by in patients with ischemic stroke. In addition, animal studies show that RIC is safe in ICH model and it could accelerate the absorption of hematoma. In a previous clinical study (RICH-1), RIC have been found to be safe and well-tolerated in patients with ICH. Therefore, the investigators plan to undertake this study to further evaluate the safety and efficacy of RIC in patients with ICH.
The investigators hypothesize that treatment with RIC will accelerate the absorption of hematoma and improve patients' functional outcomes. Results of this study can potentially bring into account new means to improve the outcomes of ICH patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment. |
|
| Sham group | Placebo Comparator | Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Device | RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | The mRS ranges from 0 to 6, with higher scores indicating worse outcome. The primary outcome measure is the mRS score, dichotomized to define favorable functional outcome as mRS 0-2 at 90 days. | 0-90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With mRS Score 0-3 at 90 Days | The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. | 90 days |
| Proportion of Patients With mRS Score 0-2 at 180 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of intracerebral hematoma volume | Intracerebral hematoma volume (ml) is assessed by CT brain scan | 0-7 days after enrollment. |
| Changes of perihematomal edema volume | Perihematomal edema volume (ml) is assessed by CT brain scan |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD, PhD | Contact | 010-83199430 | jixm@ccmu.edu.cn | |
| Wenbo Zhao, MD, PhD | Contact | 86-13120136877 | zhaowb@xwh.ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Active, not recruiting | Beijing | Beijing Municipality | 100053 | China | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33174815 | Background | Shoamanesh A, Patrice Lindsay M, Castellucci LA, Cayley A, Crowther M, de Wit K, English SW, Hoosein S, Huynh T, Kelly M, O'Kelly CJ, Teitelbaum J, Yip S, Dowlatshahi D, Smith EE, Foley N, Pikula A, Mountain A, Gubitz G, Gioia LC. Canadian stroke best practice recommendations: Management of Spontaneous Intracerebral Hemorrhage, 7th Edition Update 2020. Int J Stroke. 2021 Apr;16(3):321-341. doi: 10.1177/1747493020968424. Epub 2020 Nov 11. | |
| 26022637 |
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|
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| Sham remote ischemic conditioning | Device | Sham RIC will be performed by the same electric autocontrol device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (30 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment. |
|
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| Standard medication therapy | Drug | Standard medication therapy will be performed according to the national and international guidelines. |
|
The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. |
| 180 days |
| Proportion of Patients With mRS Score 0-3 at 180 Days | The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. | 180 days |
| Number of Subjects Experiencing Serious Adverse Events | Number of subjects experiencing Serious adverse events at any time from randomization through day 90 | 90 days |
| Number of Subjects With Serious Adverse Events Within 7 Days | Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization | 7 days |
| 0-7 days after enrollment. |
| Ordinal Distribution of Scores on mRS at Day 90 | The overall ordinal distribution of scores on mRS at 90 days in all subjects of two groups will be determined. | 90 days |
| Ordinal Distribution of Scores on mRS at Day 180 | The overall ordinal distribution of scores on mRS at 180 days in all subjects of two groups will be determined. | 180 days |
| Beijing Red Cross Emergency Rescue Center |
| Active, not recruiting |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Renhe Hospital | Not yet recruiting | Beijing | Beijng | China |
|
| Chengde Central Hospital | Recruiting | Chengde | Hebei | China |
|
| The Six People's Hospital of Hengshui | Recruiting | Hengshui | Hebei | China |
|
| Nanshi Hospital of Nanyang | Recruiting | Nanyang | Henan | China |
|
| Tongliao Municipal Hosptial | Not yet recruiting | Tongliao | Inner Mongolia | China |
|
| The First People's Hospital of Changzhou | Recruiting | Changzhou | Jiangsu | China |
|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
|
| Tianjin Huanhu Hospital | Recruiting | Tianjin | Tianjin Municipality | 300350 | China |
|
| Jiaxing Second Hospital | Not yet recruiting | Jiaxing | Zhejiang | China |
|
| Shaoxing People's Hospital | Recruiting | Shaoxing | Zhejiang | 312000 | China |
|
| Zhuji People's Hospital of Zhejaing Province | Active, not recruiting | Zhuji | Zhejiang | China |
| Background |
| Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28. |
| 33739197 | Background | Zhao W, Jiang F, Li S, Liu G, Wu C, Wang Y, Ren C, Zhang J, Gu F, Zhang Q, Gao X, Gao Z, Song H, Ma Q, Ding Y, Ji X; RICH-1 Investigators. Safety and efficacy of remote ischemic conditioning for the treatment of intracerebral hemorrhage: A proof-of-concept randomized controlled trial. Int J Stroke. 2022 Apr;17(4):425-433. doi: 10.1177/17474930211006580. Epub 2021 Apr 7. |
| 42011250 | Derived | Zhao W, Wang J, Yu X, Wu G, Yang S, Lu D, Gao X, He Y, Niu L, Zhou H, Xuan C, Li N, Zhong M, Zhang J, Dong Q, Geng X, Ma Q, Song H, Yin Y, Liu L, Hess DC, Anderson CS, Li S, Ji X; RICH-2 Investigators. Remote ischaemic conditioning in patients with supratentorial intracerebral haemorrhage (RICH-2): a multicentre, randomised, sham-controlled phase 3 trial in China. EClinicalMedicine. 2026 Apr 13;95:103900. doi: 10.1016/j.eclinm.2026.103900. eCollection 2026 May. |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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