Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation
- Conditions
- Disseminated Intravascular CoagulationSepsis
- Interventions
- Drug: Saline
- Registration Number
- NCT02654561
- Lead Sponsor
- China Medical University, China
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Heparin Saline 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. Saline Saline - Heparin Heparin Sodium 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.
- Primary Outcome Measures
Name Time Method ICU mortality during ICU stay (up to day 28) The mortality during ICU stay
- Secondary Outcome Measures
Name Time Method 28-day all-cause mortality after 28 days of enrollment of all the cases The all-cause mortality at day 28 after enrollment
the incidence of major bleeding during ICU stay (up to day 28) "Major bleeding" is defined as intracranial bleeding, life-threatening bleeding, or need red blood cell suspension more than 3 units every 24 hours,and last for 2 days
Trial Locations
- Locations (17)
The fist Affiliated Hospital Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Xiangya Third Hospital of Central South University
🇨🇳Changsha, Hunan, China
First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Zhongda Hospital
🇨🇳Nanjing, Jiangsu, China
Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Qilu Hospital of Shandong University（qingdao）
🇨🇳Qingdao, Shandong, China
Changgeng Hospital of Tsinghua University
🇨🇳Beijing, China
Shenyang Fourth People's Hospital
🇨🇳Shenyang, Liaoning, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
second Affiliated Hospital of china Medical University
🇨🇳Shenyang, Liaoning, China
the Second Affiliated Hospital of Kunming University
🇨🇳Kunming, Yunnan, China
People's Hospital of Peking University
🇨🇳Beijing, China
Beijing Friendship Hospital ， Capital Medical University
🇨🇳Beijing, China
First Affiliated Hospital of Jilin Medical University
🇨🇳Jilin, China
Qinhuangdao First Hospital
🇨🇳Qinhuangdao, China
Liaoning Provincial People's Hospital
🇨🇳Shenyang, China