Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 17
- 主要终点
- ICU mortality
研究概览
简要总结
The primary objective of this study is to estimate the efficacy of unfractionated heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association for Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of UFH in severe sepsis patients with suspected DIC.
详细描述
During the study, the whole process of data validation and registry procedures will be implemented by the Principal Investigator of the study, and monitored by the Ethics Committee of the First Affiliated Hospital of China Medical University.There are 2 research supervisors(2 ICU doctors) to assess the accuracy, completeness and representativeness of registry data, and to report the study process and research results to Principal Investigator.Investigators have also edited a data dictionary including each variable used by the registry and normal ranges of all detection indexes. The standard operating procedures have been formulated to address the registry and data analysis. The feasibility and significance have been assessed carefully and funded by the Health and Family Planning Commission of Liaoning Province(No.LNCC-B01-2014).The sample size is 600 participants through statistic calculation. The plan for missing data and statistical analysis will be implemented by specialized statisticians of China Medical University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of severe sepsis or/and septic shock
- •suspected DIC:the score of Platelets plus International Normalized Ratio in the JAAM criteria is equal or more than 3 scores
排除标准
- •consent declined
- •pregnant or breastfeeding
- •the length during ICU is less than 24 hours
- •with other types of shock
- •have bleeding or high risk for bleeding
- •have an indication for therapeutic anticoagulation
- •have a known or suspected adverse reaction to UFH including HIT
- •are currently enrolled in another trial
- •known or suspected cirrhosis or other severe hepatic diseases
- •terminal illness with a life expectancy of less than 28 days
研究组 & 干预措施
Saline
干预措施: Saline (Drug)
Heparin
If severe sepsis with suspected DIC is diagnosed, the Heparin sodium(2ml:12500 units) will be administered intravenously continuously for 24 hours. The course of treatment will last 7 days or until the death or discharge.
干预措施: Heparin Sodium (Drug)
Heparin
If severe sepsis with suspected DIC is diagnosed, the Heparin sodium(2ml:12500 units) will be administered intravenously continuously for 24 hours. The course of treatment will last 7 days or until the death or discharge.
干预措施: Saline (Drug)
结局指标
主要结局
ICU mortality
时间窗: during ICU stay (up to day 28)
The mortality during ICU stay
次要结局
- 28-day all-cause mortality(after 28 days of enrollment of all the cases)
- the incidence of major bleeding(during ICU stay (up to day 28))
研究者
Xiaochun Ma,MD
MD,PhD
China Medical University, China