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

Primary Purpose

Sepsis, Disseminated Intravascular Coagulation

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Heparin Sodium
Saline
Sponsored by
China Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Severe sepsis, Disseminated intravascular coagulation, Unfractionated heparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The fist Affiliated Hospital Harbin Medical UniversityRecruiting
  • Xiangya Third Hospital of Central South UniversityRecruiting
  • Zhongda HospitalRecruiting
  • First Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • second Affiliated Hospital of china Medical UniversityRecruiting
  • Shenyang Fourth People's HospitalRecruiting
  • Qilu Hospital of Shandong University（qingdao）Recruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • the Second Affiliated Hospital of Kunming UniversityRecruiting
  • Beijing Friendship Hospital ， Capital Medical UniversityRecruiting
  • Changgeng Hospital of Tsinghua UniversityRecruiting
  • People's Hospital of Peking UniversityRecruiting
  • First Affiliated Hospital of Jilin Medical UniversityRecruiting
  • Qinhuangdao First HospitalRecruiting
  • Liaoning Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline

Heparin

Arm Description

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.

Outcomes

Primary Outcome Measures

ICU mortality

Secondary Outcome Measures

28-day all-cause mortality
The results will be represented at December 2016
the incidence of major bleeding
"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

Full Information

First Posted
August 25, 2015
Last Updated
July 22, 2019
Sponsor
China Medical University, China
Collaborators
Peking Union Medical College Hospital, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Central South University, The Second Affiliated Hospital of Harbin Medical University, Zhongda Hospital, Zhejiang Hospital, The First Affiliated Hospital of Dalian Medical University, Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02654561
Brief Title
Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation
Official Title
Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
Collaborators
Peking Union Medical College Hospital, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Central South University, The Second Affiliated Hospital of Harbin Medical University, Zhongda Hospital, Zhejiang Hospital, The First Affiliated Hospital of Dalian Medical University, Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Disseminated Intravascular Coagulation
Keywords
Severe sepsis, Disseminated intravascular coagulation, Unfractionated heparin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Title
Heparin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Heparin Sodium
Other Intervention Name(s)
Unfractionated heparin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
ICU mortality
Time Frame
1 year
Secondary Outcome Measure Information:
Title
28-day all-cause mortality
Description
The results will be represented at December 2016
Time Frame
after 28 days of enrollment of all the cases
Title
the incidence of major bleeding
Description
"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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaochun Ma, M.D.
Phone
0086-18040097989
Email
xuanfeng7890@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xin li, Doctor
Phone
0086-13842059580
Email
xuanfeng7890@163.com
Facility Information:
Facility Name
The fist Affiliated Hospital Harbin Medical University
City
Haerbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei yang, master
First Name & Middle Initial & Last Name & Degree
mingyan zhao, doctor
Facility Name
Xiangya Third Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
min gao
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Qi, MD
First Name & Middle Initial & Last Name & Degree
chun pan, MD
First Name & Middle Initial & Last Name & Degree
chun pan, doctor
Facility Name
First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xianyao wan
First Name & Middle Initial & Last Name & Degree
chen chen, master
Facility Name
Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jian yu
First Name & Middle Initial & Last Name & Degree
dandan zhu
Facility Name
second Affiliated Hospital of china Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bin zang, doctor
First Name & Middle Initial & Last Name & Degree
di chang, master
Facility Name
Shenyang Fourth People's Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei feng
First Name & Middle Initial & Last Name & Degree
yinan guo, master
Facility Name
Qilu Hospital of Shandong University（qingdao）
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dawei wu
First Name & Middle Initial & Last Name & Degree
chanyuan bu, master
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yan kang
First Name & Middle Initial & Last Name & Degree
qin sun, doctor
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chuanyun qian
First Name & Middle Initial & Last Name & Degree
li wang
Facility Name
the Second Affiliated Hospital of Kunming University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qingqing huang, doctor
First Name & Middle Initial & Last Name & Degree
yuanyuan wang, doctor
First Name & Middle Initial & Last Name & Degree
yuangyuan wang, doctor
Facility Name
Beijing Friendship Hospital ， Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
meili duan
First Name & Middle Initial & Last Name & Degree
yu qiu, doctor
Facility Name
Changgeng Hospital of Tsinghua University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuan xu
Facility Name
People's Hospital of Peking University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
youzhong an, doctor
First Name & Middle Initial & Last Name & Degree
jie lv, doctor
Facility Name
First Affiliated Hospital of Jilin Medical University
City
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dong zhang
First Name & Middle Initial & Last Name & Degree
lina gu
Facility Name
Qinhuangdao First Hospital
City
Qinhuangdao
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiujuan liu
Facility Name
Liaoning Provincial People's Hospital
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xinghuo feng
First Name & Middle Initial & Last Name & Degree
chengshu dong, master

12. IPD Sharing Statement

Citations:
PubMed Identifier
17147870
Citation
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.
Results Reference
background
PubMed Identifier
19957797
Citation
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.
Results Reference
background
PubMed Identifier
19242322
Citation
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.
Results Reference
background
PubMed Identifier
24520253
Citation
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.
Results Reference
background
PubMed Identifier
14680357
Citation
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.
Results Reference
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Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation

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