Jun Wu1,2, Xinguo Sun3, Qingyuan Liu1,2, Maogui Li1,2, Shanwen Chen4, Jiantao Wang5, Youquan Wang6, Peng Guo7, Xiong Li7, Lei Peng8, Pengjun Jiang1,2, Nuochuan Wang9, Rui Guo1,2, Shuzhe Yang1,2, Yong Cao1,2, Bo Ning10, Cang Liu8, Fuzheng Zhang6, Jingping Li7, Yanan Zhang11, Shuo Wang12,13. 1. Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, 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, Binzhou People's Hospital, Binzhou, 256610, Shandong, China. 4. Department of Neurosurgery, Beijing Shunyi District Hospital, No. 3 Guangming Nan Street, Shunyi District, Beijing, 101300, China. 5. Department of Neurosurgery, Beijing Anzhen Hospital, Capital Medical University, No.2 Anzhen Road, Chaoyang District, Beijing, 100029, China. 6. Department of Neurosurgery, Beijing Pinggu District Hospital, 59 Xinping Bei Lu, Pinggu District, Beijing, China. 7. Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University, No.8 Gongti South Road, Chaoyang District, Beijing, 100020, China. 8. Department of Neurosurgery, Beijing Friendship Hospital, Capital Medical University, No.95 Yongan Road, Xicheng District, Beijing, 100020, China. 9. Department of Blood Transfusion, Beijing Tiantan Hospital, Capital Medical University, No.119 South 4th Ring West Road, Fengtai District, Beijing, 100070, China. 10. Department of Neurosurgery, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, 510220, Guangdong, China. 11. Department of Blood Transfusion, Beijing Tiantan Hospital, Capital Medical University, No.119 South 4th Ring West Road, Fengtai District, Beijing, 100070, China. zhangyanan@bjtth.org. 12. Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, No.119 South 4th Ring West Road, Fengtai District, Beijing, 100070, China. captain9858@126.com. 13. China National Clinical Research Center for Neurological Diseases, Beijing, People's Republic of China. captain9858@126.com.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION: 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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