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

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University, China
• Collaborators: Central South University; First Affiliated Hospital, Sun Yat-Sen University; Peking Union Medical College Hospital; Shengjing Hospital; The First Affiliated Hospital of Dalian Medical University; The Second Affiliated Hospital of Harbin Medical University; West China Hospital; Zhejiang Hospital; Zhongda Hospital
• Treatments: Calcium heparin; Heparin

Criteria

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