Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC
Who is this study for? Adult patients with Sepsis
What treatments are being studied? Heparin
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing Friendship Hospital ， Capital Medical University
RECRUITING
Beijing
Changgeng Hospital of Tsinghua University
RECRUITING
Beijing
People's Hospital of Peking University
RECRUITING
Beijing
Xiangya Third Hospital of Central South University
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Second Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
The fist Affiliated Hospital Harbin Medical University
RECRUITING
Haerbin
First Affiliated Hospital of Jilin Medical University
RECRUITING
Jilin
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
the Second Affiliated Hospital of Kunming University
RECRUITING
Kunming
Zhongda Hospital
RECRUITING
Nanjing
Qilu Hospital of Shandong University（qingdao）
RECRUITING
Qingdao
Qinhuangdao First Hospital
RECRUITING
Qinhuangdao
Liaoning Provincial People's Hospital
RECRUITING
Shenyang
second Affiliated Hospital of china Medical University
RECRUITING
Shenyang
Shenyang Fourth People's Hospital
RECRUITING
Shenyang
Contact Information
Primary
Xiaochun Ma, M.D.
maxc_cmu@sina.com
0086-13840192939
Backup
Yini Sun, Ph.D
sunyini_1006@163.com
0086-13700017130
Time Frame
Start Date: 2018-04-12
Estimated Completion Date: 2025-06
Participants
Target number of participants: 600
Treatments
Placebo_comparator: Saline
Experimental: 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.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Nanchang University, Beijing Tsinghua Changgeng Hospital, The First Affiliated Hospital of Dalian Medical University, The People's Hospital of Liaoning Province, West China Hospital, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Qingdao University, General Hospital of Ningxia Medical University, Fourth People's Hospital of Shenyang, Shengjing Hospital, Peking University People's Hospital, Zhongda Hospital, Qilu Hospital of Shandong University, The Second Affiliated Hospital of Kunming Medical University, Beijing Friendship Hospital, The First Hospital of Jilin University, First Affiliated Hospital of Harbin Medical University, The First Hospital of Qinhuangdao
Leads: China Medical University, China