Wu Qin, Ren Jianan, Wang Gefei, Gu Guosheng, Hu Dong, Liu Song, Li Gunawei, Chen Jun, Li Ranran, Hong Zhiwu, Ren Huajian, Wu Xiuwen, Li Yuan, Yao Min, Zhao Yunzhao, Li Jieshou
Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, 305 East Zhong Shan Road, Nanjing, 210002, China.
Department of Surgery, VA Medical Center, 830 Chalkstone Avenue, Providence, RI, 02908, USA.
Trials. 2015 May 19;16:220. doi: 10.1186/s13063-015-0746-6.
Sepsis is still a major health problem that causes high mortality in all populations. Organ dysfunction including sepsis-associated thrombocytopenia is prevalent among sepsis patients, resulting in increasing mortality rates. Considering the clinical role of platelets, thrombocytopenia in sepsis has led to a large spend in research activity and clinical trials in this area, yet there is no consensus upon which treatment should be administered. As a result, platelet transfusion is often indicated to resolve low platelet counts, leading to an increasing risk of the multiple risks transfusion brings, such as infectious or immune system complications. Given the role of thrombopoietin in stimulating proliferation and differentiation of megakaryocytes, our previous study investigated the potential benefits of recombinant human thrombopoietin in severe sepsis patients with thrombocytopenia. However, there are several limitations in the study, which may have led to bias in our conclusion. Thus, we are conducting this study in order to evaluate the safety and efficacy of recombinant human thrombopoietin in a large, varied population.
METHODS/DESIGN: The study is designed as a randomized, open-label, placebo-controlled, multi-center study in tertiary academic centers for evaluating the safety and efficacy of recombinant human thrombopoietin over placebo. An established total of 708 patients with sepsis and thrombocytopenia will undergo prospective random assignment to recombinant human thrombopoietin or placebo (a 1:1 ratio). The primary endpoint is 7-day all-cause mortality and 28-day all-cause mortality.
To our knowledge, this is the first study to evaluate the safety and efficacy of recombinant human thrombopoietin among severe sepsis patients with thrombocytopenia in a varied population. With our study, the level of evidence for the treatment of these patients will be significantly raised.
ClinicalTrials.gov: NCT02094248 . Registration date: 23 March 2014.
脓毒症仍然是一个主要的健康问题，在所有人群中都导致高死亡率。包括脓毒症相关血小板减少症在内的器官功能障碍在脓毒症患者中很普遍，导致死亡率不断上升。考虑到血小板的临床作用，脓毒症中的血小板减少症已引发该领域大量的研究活动和临床试验，但对于应采用何种治疗方法尚无共识。因此，常采用血小板输注来解决血小板计数过低的问题，这增加了输血带来的多种风险，如感染或免疫系统并发症。鉴于血小板生成素在刺激巨核细胞增殖和分化中的作用，我们之前的研究调查了重组人血小板生成素对严重脓毒症血小板减少症患者的潜在益处。然而，该研究存在一些局限性，可能导致我们的结论存在偏差。因此，我们正在进行这项研究，以评估重组人血小板生成素在大量不同人群中的安全性和有效性。
方法/设计：本研究设计为在三级学术中心进行的随机、开放标签、安慰剂对照、多中心研究，以评估重组人血小板生成素相对于安慰剂的安全性和有效性。总共708例脓毒症和血小板减少症患者将被前瞻性随机分配接受重组人血小板生成素或安慰剂（1:1比例）。主要终点是7天全因死亡率和28天全因死亡率。
据我们所知，这是第一项评估重组人血小板生成素在大量不同人群的严重脓毒症血小板减少症患者中的安全性和有效性的研究。通过我们的研究，治疗这些患者的证据水平将显著提高。
ClinicalTrials.gov：NCT02094248。注册日期：2014年3月23日。
