Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation
NCT ID: NCT02654561
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2018-04-12
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Saline
Saline
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.
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.
Heparin Sodium
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.
Saline
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.
Interventions
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Heparin Sodium
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.
Saline
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* suspected DIC:the score of Platelets plus International Normalized Ratio in the JAAM criteria is equal or more than 3 scores
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Zhongda Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Shengjing Hospital
OTHER
The First Hospital of Jilin University
OTHER
Qilu Hospital of Shandong University
OTHER
The Second Affiliated Hospital of Kunming Medical University
OTHER
The First Hospital of Qinhuangdao
OTHER_GOV
The Second Affiliated Hospital of Dalian Medical University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Peking University People's Hospital
OTHER
The People's Hospital of Liaoning Province
OTHER
Fourth People's Hospital of Shenyang
OTHER
Beijing Tsinghua Changgeng Hospital
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Beijing Friendship Hospital
OTHER
General Hospital of Ningxia Medical University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
China Medical University, China
OTHER
Responsible Party
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Xiaochun Ma,MD
MD,PhD
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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wei yang, master
Role: primary
min gao
Role: primary
Haibo Qiu, MD
Role: primary
chun pan, MD
Role: backup
xianyao wan
Role: primary
jian yu
Role: primary
bin zang, doctor
Role: primary
wei feng
Role: primary
dawei wu
Role: primary
yan kang
Role: primary
chuanyun qian
Role: primary
qingqing huang, doctor
Role: primary
yuanyuan wang, doctor
Role: backup
meili duan
Role: primary
yuan xu
Role: primary
youzhong an, doctor
Role: primary
dong zhang
Role: primary
xiujuan liu
Role: primary
xinghuo feng
Role: primary
References
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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.
Zhao 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.
Jaimes 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.
Liu 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.
Barkun 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.
Sun 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.
Other Identifiers
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LNCCC-B01-2014
Identifier Type: -
Identifier Source: org_study_id
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