Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation

China Medical University, China

Status and phase: Enrolling; Phase 3

Conditions: Disseminated Intravascular Coagulation; Sepsis

Treatments: Drug: Heparin Sodium; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02654561

LNCCC-B01-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Treatment:

Drug: Saline

Heparin

Experimental group

Description:

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.

Treatment:

Drug: Saline

Drug: Heparin Sodium