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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC

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 Summary: 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 700 participants over about 1 year through statistic calculation. The plan for missing data and statistical analysis will be implemented by specialized statisticians of China Medical University.
Sponsor: China Medical University, China

Current Primary Outcome: ICU mortality [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 28-day all-cause mortality [ Time Frame: after 28 days of enrollment of all the cases ]
  The results will be represented at December 2016
• the incidence of major bleeding [ Time Frame: 1 year ]
  "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

Original Secondary Outcome: Same as current

Information By: China Medical University, China

Dates:
Date Received: August 25, 2015
Date Started: May 2016
Date Completion: June 2017
Last Updated: January 12, 2016
Last Verified: August 2015