EXPRESS: Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Proof-of-Concept Randomized Controlled Trial.
机构:[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China神经科系统神经内科首都医科大学宣武医院[2]Beijing Institute of Brain Disorders, Capital Medical University, Beijing, China[3]Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China科技平台低氧适应转化医学北京市重点实验室首都医科大学宣武医院[4]Department of Neurology, Ningjin County Hospital, Xingtai, China[5]Department of Neurosurgery, Heze Municipal Hospital, Heze, China[6]Department of Neurosurgery, The Sixth Hospital of Hengshui, Hengshui, China[7]Department of Neurology, Shengli Oilfield Central Hospital, Dongying, China[8]Department of Neurosurgery, Wayne State University School of Medicine, Detroit, MI, USA[9]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China神经科系统神经外科首都医科大学宣武医院
Background Remote ischemic conditioning (RIC) can promote hematoma resolution, attenuate brain edema, and improve neurological recovery in animal models of intracerebral hemorrhage (ICH). Aims This study aimed to evaluate the safety and preliminary efficacy of RIC in patients with ICH.Methods In this multicenter, randomized, controlled trial, 40 subjects with supratentorial ICH presenting within 24-48 hours of onset were randomly assigned to receive medical therapy plus RIC for consecutive 7 days or medical therapy alone. The primary safety outcome was neurological deterioration within 7 days of enrollment, and the primary efficacy outcome was the changes of hematoma volume on CT images. Other outcomes included hematoma resolution rate at 7 d ([hematoma volume at 7 d â hematoma volume at baseline]/hematoma volume at baseline), perihematomal edema (PHE), and functional outcome at 90 days. Results The mean age was 59.3±11.7 years and hematoma volume was 13.9±4.5 mL. No subjects experienced neurological deterioration within 7 days of enrollment, and no subject died or experienced RIC-associated adverse events during the study period. At baseline, the hematoma volumes were 14.19±5.07 mL in the control group and 13.55±3.99 mL in the RIC group, and they were 8.54±3.99 mL and 6.95±2.71 mL at 7 days after enrollment, respectively, not a significant difference (p>0.05 each). The hematoma resolution rate in the RIC group (49.25±9.17%) was significantly higher than in the control group (41.92±9.14%; MD, 7.3%; 95% CI, 1.51% to 13.16%; p=0.015). The absolute PHE volume was 17.27±8.34 mL in the control group and 12.92±7.30 mL in the RIC group at 7 days after enrollment, not a significant between-group difference (p=0.087), but the relative PHE in the RIC group (1.77±0.39) was significantly lower than in the control group (2.02±0.27; MD, 0.25; 95% CI, 0.39-0.47; p=0.023). At 90-day follow-up, 13 subjects (65%) in the RIC group and 12 subjects (60%) in the control group achieved favorable functional outcomes (mRS scoreâ¤3), not a significant between-group difference (p=0.744).Conclusions Repeated daily RIC for consecutive 7 days was safe and well-tolerated in patients with ICH, and it may be able to improve hematoma resolution rate and reduce relative PHE. However, effects RIC on the absolute hematoma and PHE volume and functional outcomes in this patient population need further investigations.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03930940.
基金:
Beijing Nova Program (No. Z201100006820143) from Beijing
Municipal Science & Technology Commission, General Project of Science and Technology
(No. KM202110025018) from Beijing Municipal Education Commission, the National
Natural Science Foundation of China (No. 82001257), grant 2019A36 from Beijing Hundred
Thousand and Ten Thousand Talent Project, and Beijing Municipal Administration of
Hospitals Incubating Program (PX2018033).
第一作者机构:[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China[2]Beijing Institute of Brain Disorders, Capital Medical University, Beijing, China[3]Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China
共同第一作者:
通讯作者:
通讯机构:[*1]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing, 100053, China.
推荐引用方式(GB/T 7714):
Wenbo Zhao,Fang Jiang,Sijie Li,et al.EXPRESS: Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Proof-of-Concept Randomized Controlled Trial.[J].INTERNATIONAL JOURNAL OF STROKE.2022,17(4):425-433.doi:10.1177/17474930211006580.
APA:
Wenbo Zhao,Fang Jiang,Sijie Li,Guiyou Liu,Chuanjie Wu...&for the RICH Investigators.(2022).EXPRESS: Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Proof-of-Concept Randomized Controlled Trial..INTERNATIONAL JOURNAL OF STROKE,17,(4)
MLA:
Wenbo Zhao,et al."EXPRESS: Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Proof-of-Concept Randomized Controlled Trial.".INTERNATIONAL JOURNAL OF STROKE 17..4(2022):425-433