Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.
Department of Clinical Epidemiology and Evidence-based Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.
Trials. 2024 Jan 2;25(1):4. doi: 10.1186/s13063-023-07853-5.
Disseminated intravascular coagulation (DIC) occurs in 30-50% of septic patients and contributes to high mortality in the intensive care unit (ICU). However, there are few proven interventions for coagulation disorder management in sepsis. Experimental and clinical data have demonstrated that sepsis could benefit from unfractionated heparin (UFH) treatment. To date, there are no large multicenter trials to determine the safety and efficacy of UFH in septic patients with suspected DIC.
A multicenter, double-blinded, placebo-controlled randomized trial is designed to recruit 600 patients who met sepsis 3.0 criteria and suspected DIC. Participants will be randomized (1:1) to receive UFH or saline via continuous intravenous administration for 7 days within 6 h of enrolment. The primary outcome is ICU mortality. The secondary outcome includes 28-day all-cause mortality, the improvement of Sequential Organ Failure Assessment scores, and the incidence of major hemorrhage. Investigators, participants, and statisticians will be blinded to the allocation.
The HepSIC trial is to evaluate the efficacy and safety of UFH on sepsis-related DIC across different areas of China. The small dosage of UFH administration would offer a new potential approach for treating sepsis-related coagulation disorders.
Ethical approval was granted by all the ethics committees of 20 participant centers. Results will be disseminated via peer-reviewed publications and presented at conferences.
ClinicalTrials.gov NCT02654561. Registered on 13 January 2016.
弥散性血管内凝血（DIC）发生于 30%-50%的脓毒症患者，导致重症监护病房（ICU）死亡率较高。然而，针对脓毒症凝血障碍管理，仅有少数经证实的干预措施。实验和临床数据表明，肝素（UFH）治疗可能对脓毒症有益。迄今为止，尚无大型多中心试验来确定 UFH 在疑似 DIC 的脓毒症患者中的安全性和疗效。
本研究是一项多中心、双盲、安慰剂对照随机试验，计划纳入符合 3.0 版脓毒症标准且疑似 DIC 的 600 例患者。患者将在入组后 6 小时内，按 1:1 的比例随机（分配）接受 UFH 或生理盐水连续静脉输注 7 天。主要结局为 ICU 死亡率。次要结局包括 28 天全因死亡率、序贯器官衰竭评估（SOFA）评分的改善以及大出血的发生率。研究者、参与者和统计人员将对分组情况设盲。
HepSIC 试验旨在评估 UFH 在中国不同地区治疗脓毒症相关 DIC 的疗效和安全性。UFH 的小剂量给药可能为治疗脓毒症相关凝血障碍提供新的潜在方法。
本研究已获得 20 个参与中心的所有伦理委员会的批准。结果将通过同行评审的出版物进行传播，并在会议上展示。
ClinicalTrials.gov NCT02654561。于 2016 年 1 月 13 日注册。
