Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage
NCT ID: NCT04657133
Last Updated: 2022-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
452 participants
INTERVENTIONAL
2021-04-22
2023-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention group
Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.
Remote ischemic conditioning
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.
Standard medication therapy
Standard medication therapy will be performed according to the national and international guidelines.
Sham group
Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment alone.
Sham remote ischemic conditioning
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.
Standard medication therapy
Standard medication therapy will be performed according to the national and international guidelines.
Interventions
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Remote ischemic conditioning
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.
Sham remote ischemic conditioning
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.
Standard medication therapy
Standard medication therapy will be performed according to the national and international guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The diagnosis of supratentorial ICH is confirmed by brain CT scan
3. Hematoma volume of 10 to 30 ml and Glasgow Coma Score (GCS)\>8 at randomization.
4. National Institutes of Health Stroke Scale (NIHSS)≥6 and ≤20 points at randomization.
5. Randomization and starting treatment between 24 and 48 hours of symptom ictus.
6. Signed and dated informed consent is obtained.
Exclusion Criteria
2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage
3. Suspected secondary ICH related to tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
4. Patients with a pre-existing neurological deficit (mRS\>1) or psychiatric disease that would confound the neurological or functional evaluations.
5. Coagulopathy - defined as elevated aPTT or INR \>1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban or apixaban), or low-molecular-weight heparin
6. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR \<30ml/min/1.73m2
7. Severe liver disorder, or ALT \>3 times or bilirubin \>2 times upper limit of normal
8. Known severe hearing loss or cognitive impairment
9. Known pregnancy, or positive pregnancy test, or breastfeeding
10. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, noncompliance or any other cause
11. Life expectancy of less than 90 days due to co-morbid conditions
12. Concurrent participation in another research protocol for investigation of another experimental therapy
13. Severe, sustained hypertension (Systolic blood pressure\> 180 mmHg or diastolic blood pressure\> 110 mmHg).
14. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
15. Any condition which, in the judgement of the investigator, might increase the risk to the patient.
18 Years
80 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Professor
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Red Cross Emergency Rescue Center
Beijing, Beijing Municipality, China
Beijing Renhe Hospital
Beijing, Beijng, China
Chengde Central Hospital
Chengde, Hebei, China
The Six People's Hospital of Hengshui
Hengshui, Hebei, China
Nanshi Hospital of Nanyang
Nanyang, Henan, China
Tongliao Municipal Hosptial
Tongliao, Inner Mongolia, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Zhuji People's Hospital of Zhejaing Province
Zhuji, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Na Li, M.D.
Role: primary
Jiangtao Zhang
Role: primary
Xinjing Gao
Role: primary
Rongyao Ma
Role: primary
Yaoming Xu, M.D.
Role: primary
Song Yang, M.D.
Role: primary
Deqin Geng, MD
Role: primary
Ming Wei, MD
Role: primary
Jianguo Shen
Role: primary
Xuebin Yu, MD
Role: primary
References
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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.
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.
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.
Other Identifiers
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RICH-2
Identifier Type: -
Identifier Source: org_study_id
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