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Surgical treatment for antiplatelet intracerebral hemorrhage (SAP-ICH): protocol for a prospective cohort study of emergency surgery for severe spontaneous intracerebral hemorrhage patients on long-term oral antiplatelet treatment.

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收录情况: ◇ CSCD-C ◇ 卓越:梯队期刊 ◇ 中华系列

单位: [1]Department of Neurosurgery, Beijing Tiantan Hospital, Capital MedicalUniversity, No.119 South 4th Ring West Road, Fengtai District, Beijing 100070,China [2]China National Clinical Research Center for Neurological Diseases,Beijing, People’s Republic of China [3]Department of Neurosurgery, BinzhouPeople’s Hospital, Binzhou 256610, Shandong, China [4]Department ofNeurosurgery, Beijing Shunyi District Hospital, No. 3 Guangming Nan Street,Shunyi District, Beijing 101300, China [5]Department of Neurosurgery, BeijingAnzhen Hospital, Capital Medical University, No.2 Anzhen Road, ChaoyangDistrict, Beijing 100029, China [6]Department of Neurosurgery, Beijing PingguDistrict Hospital, 59 Xinping Bei Lu, Pinggu District, Beijing, China. [7]Department of Neurosurgery, Beijing Chaoyang Hospital, Capital MedicalUniversity, No.8 Gongti South Road, Chaoyang District, Beijing 100020, China [8]Department of Neurosurgery, Beijing Friendship Hospital, Capital MedicalUniversity, No.95 Yongan Road, Xicheng District, Beijing 100020, China [9]Department of Blood Transfusion, Beijing Tiantan Hospital, Capital MedicalUniversity, No.119 South 4th Ring West Road, Fengtai District, Beijing 100070,China [10]Department of Neurosurgery, Guangzhou Red Cross Hospital, JinanUniversity, Guangzhou 510220, Guangdong, China.
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Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT.As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSICH patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage.In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established.In this study, we will investigate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.The research protocol and informed consent in this study were approved by the Institutional Review Board of Beijing Tiantan Hospital (KY2019-096-02). The results of this study are expected to be disseminated in peer-reviewed journals in 2023.Name: Effect and safety of surgical intervention for severe spontaneous intracerebral hemorrhage patients on long-term oral antiplatelet treatment. ChiCTR1900024406 . Date of registration is July 10, 2019.

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第一作者单位: [1]Department of Neurosurgery, Beijing Tiantan Hospital, Capital MedicalUniversity, No.119 South 4th Ring West Road, Fengtai District, Beijing 100070,China [2]China National Clinical Research Center for Neurological Diseases,Beijing, People’s Republic of China
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通讯机构: [1]Department of Neurosurgery, Beijing Tiantan Hospital, Capital MedicalUniversity, No.119 South 4th Ring West Road, Fengtai District, Beijing 100070,China [2]China National Clinical Research Center for Neurological Diseases,Beijing, People’s Republic of China
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