Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation
Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC
1 other identifier
interventional
600
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 sepsis
Started Apr 2018
Longer than P75 for phase_3 sepsis
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedStudy Start
First participant enrolled
April 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedNovember 18, 2023
November 1, 2023
6.6 years
August 25, 2015
November 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ICU mortality
The mortality during ICU stay
during ICU stay (up to day 28)
Secondary Outcomes (2)
28-day all-cause mortality
after 28 days of enrollment of all the cases
the incidence of major bleeding
during ICU stay (up to day 28)
Other Outcomes (2)
Change in SOFA scores
during the intervention period (up to day 7 after enrollment)
Change in JAAM and ISTH scores
during the intervention period (up to day 7 upon enrollment)
Study Arms (2)
Saline
PLACEBO COMPARATORHeparin
EXPERIMENTALIf 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.
Interventions
A bottle solution of Heparin Sodium(2ml:12500IU) is added to 50ml saline and administered i.v. continuously for 24 hours, which last 7 days or until the death or discharge. The same amount of 0.9% saline as the heparin group will be administered in the placebo group.
For all the severe sepsis or septic shock patients, normal saline will be administered for fluid resuscitation according to the Guideline of Survival Sepsis Campaign.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China Medical University, Chinalead
- West China Hospitalcollaborator
- Zhongda Hospitalcollaborator
- The First Affiliated Hospital of Dalian Medical Universitycollaborator
- Shengjing Hospitalcollaborator
- The First Hospital of Jilin Universitycollaborator
- Qilu Hospital of Shandong Universitycollaborator
- The Second Affiliated Hospital of Kunming Medical Universitycollaborator
- The First Hospital of Qinhuangdaocollaborator
- The Second Affiliated Hospital of Dalian Medical Universitycollaborator
- First Affiliated Hospital of Harbin Medical Universitycollaborator
- Peking University People's Hospitalcollaborator
- The People's Hospital of Liaoning Provincecollaborator
- Fourth People's Hospital of Shenyangcollaborator
- Beijing Tsinghua Changgeng Hospitalcollaborator
- First Affiliated Hospital of Kunming Medical Universitycollaborator
- The Affiliated Hospital of Qingdao Universitycollaborator
- Beijing Friendship Hospitalcollaborator
- General Hospital of Ningxia Medical Universitycollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
Study Sites (17)
The fist Affiliated Hospital Harbin Medical University
Haerbin, Heilongjiang, China
Xiangya Third Hospital of Central South University
Changsha, Hunan, China
Zhongda Hospital
Nanjing, Jiangsu, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
second Affiliated Hospital of china Medical University
Shenyang, Liaoning, China
Shenyang Fourth People's Hospital
Shenyang, Liaoning, China
Qilu Hospital of Shandong University（qingdao）
Qingdao, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
the Second Affiliated Hospital of Kunming University
Kunming, Yunnan, China
Beijing Friendship Hospital ， Capital Medical University
Beijing, China
Changgeng Hospital of Tsinghua University
Beijing, China
People's Hospital of Peking University
Beijing, China
First Affiliated Hospital of Jilin Medical University
Jilin, China
Qinhuangdao First Hospital
Qinhuangdao, China
Liaoning Provincial People's Hospital
Shenyang, China
Related Publications (6)
Zhang XJ, Ma XC. [Therapeutic effects of early administration of low-dose heparin in patients with severe sepsis]. Zhonghua Wai Ke Za Zhi. 2006 Sep 1;44(17):1209-11. Chinese.
PMID: 17147870BACKGROUNDZhao C, Zhang ZD, Zhang XJ, Li X, Zhu R, Ma XC. [Evaluation of clinical effects on low-dose heparin therapy for sepsis]. Zhonghua Nei Ke Za Zhi. 2009 Jul;48(7):566-9. Chinese.
PMID: 19957797BACKGROUNDJaimes F, De La Rosa G, Morales C, Fortich F, Arango C, Aguirre D, Munoz A. Unfractioned heparin for treatment of sepsis: A randomized clinical trial (The HETRASE Study). Crit Care Med. 2009 Apr;37(4):1185-96. doi: 10.1097/CCM.0b013e31819c06bc.
PMID: 19242322BACKGROUNDLiu XL, Wang XZ, Liu XX, Hao D, Jaladat Y, Lu F, Sun T, Lv CJ. Low-dose heparin as treatment for early disseminated intravascular coagulation during sepsis: A prospective clinical study. Exp Ther Med. 2014 Mar;7(3):604-608. doi: 10.3892/etm.2013.1466. Epub 2013 Dec 31.
PMID: 24520253BACKGROUNDBarkun J, Christou NV; CAGS Evidence Based Reviews in Surgery Group. Canadian Association of General Surgeons Evidence Based Reviews in Surgery. 8. Efficacy and safety of recombinant human activated protein C for severe sepsis. Can J Surg. 2003 Dec;46(6):468-70. No abstract available.
PMID: 14680357BACKGROUNDSun Y, Ding R, Sun H, Liang Y, Ma X. Efficacy and safety of heparin for sepsis-induced disseminated intravascular coagulation (HepSIC): study protocol for a multicenter randomized controlled trial. Trials. 2024 Jan 2;25(1):4. doi: 10.1186/s13063-023-07853-5.
PMID: 38167115DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
August 25, 2015
First Posted
January 13, 2016
Study Start
April 12, 2018
Primary Completion
December 1, 2024
Study Completion
June 1, 2025
Last Updated
November 18, 2023
Record last verified: 2023-11