SepsisPhase 3NCT02654561
Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation
A Phase 3 study testing Heparin Sodium and Saline in people with Sepsis and Disseminated Intravascular Coagulation, run by China Medical University, China at 17 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Disseminated Intravascular Coagulation
- What is being tested?
- Heparin Sodium and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 17 sitesChina
- Study dates
- 12 Apr 2018to Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Beijing Friendship Hospital ， Capital Medical University
Beijing
meili duan
yu qiu, doctor
- Recruiting
Changgeng Hospital of Tsinghua University
Beijing
yuan xu
- Recruiting
People's Hospital of Peking University
Beijing
youzhong an, doctor
jie lv, doctor
- Recruiting
Xiangya Third Hospital of Central South University
Changsha, Hunan
min gao
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
yan kang
qin sun, doctor
- Recruiting
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
xianyao wan
chen chen, master
- Recruiting
Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
jian yu
dandan zhu
- Recruiting
The fist Affiliated Hospital Harbin Medical University
Haerbin, Heilongjiang
wei yang, master
mingyan zhao, doctor
- Recruiting
First Affiliated Hospital of Jilin Medical University
Jilin City
dong zhang
lina gu
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
chuanyun qian
li wang
- Recruiting
the Second Affiliated Hospital of Kunming University
Kunming, Yunnan
qingqing huang, doctor
yuanyuan wang, doctor
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu
Haibo Qiu, MD
chun pan, MD
- Recruiting
Qilu Hospital of Shandong University（qingdao）
Qingdao, Shandong
dawei wu
chanyuan bu, master
- Recruiting
Qinhuangdao First Hospital
Qinhuangdao
xiujuan liu
- Recruiting
second Affiliated Hospital of china Medical University
Shenyang, Liaoning
bin zang, doctor
di chang, master
- Recruiting
Shenyang Fourth People's Hospital
Shenyang, Liaoning
wei feng
yinan guo, master
- Recruiting
Liaoning Provincial People's Hospital
Shenyang
xinghuo feng
chengshu dong, master
About this study
Official title: Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC
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.
Read the 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 600 participants through statistic calculation. The plan for missing data and statistical analysis will be implemented by specialized statisticians of China Medical University.
- Conditions
- Sepsis, Disseminated Intravascular Coagulation
- Being tested
- Heparin Sodium, Saline
- Keywords
- Severe sepsis, Disseminated intravascular coagulation, Unfractionated heparin
- Medical subject headings
- Sepsis, Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin SodiumDrug
Also called Unfractionated heparin
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.
SalineDrug
Also called Normal 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.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
| Heparin | Experimental | 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. Receives: Drug: Heparin Sodium; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
The mortality during ICU stay
Measured: during ICU stay (up to day 28)
Secondary outcomes (2)
28-day all-cause mortality
The all-cause mortality at day 28 after enrollment
Measured: after 28 days of enrollment of all the cases
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
Measured: during ICU stay (up to day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start12 Apr 2018
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Zhongda Hospital, The First Affiliated Hospital of Dalian Medical University, Shengjing Hospital, The First Hospital of Jilin University, Qilu Hospital of Shandong University, The Second Affiliated Hospital of Kunming Medical University, The First Hospital of Qinhuangdao, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Harbin Medical University, Peking University People's Hospital, The People's Hospital of Liaoning Province, Fourth People's Hospital of Shenyang, Beijing Tsinghua Changgeng Hospital, First Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Qingdao University, Beijing Friendship Hospital, General Hospital of Ningxia Medical University, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Xiaochun Ma,MD, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654561
- Sponsor's protocol ID
- LNCCC-B01-2014
- Status last verified
- Nov 2023
- First submitted
- 25 Aug 2015
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17147870Zhao 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.
PubMed 19957797Jaimes 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.
PubMed 19242322Liu 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.
PubMed 24520253Barkun 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.
PubMed 14680357Sun 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.
PubMed 38167115
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC
- ClinicalTrials.gov ID
- NCT02654561
- Acronym / sponsor ID
- LNCCC-B01-2014
- Conditions
- Sepsis, Disseminated Intravascular Coagulation
- Keywords
- Severe sepsis, Disseminated intravascular coagulation, Unfractionated heparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- West China Hospital, Zhongda Hospital, The First Affiliated Hospital of Dalian Medical University, Shengjing Hospital, The First Hospital of Jilin University, Qilu Hospital of Shandong University, The Second Affiliated Hospital of Kunming Medical University, The First Hospital of Qinhuangdao, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Harbin Medical University, Peking University People's Hospital, The People's Hospital of Liaoning Province, Fourth People's Hospital of Shenyang, Beijing Tsinghua Changgeng Hospital, First Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Qingdao University, Beijing Friendship Hospital, General Hospital of Ningxia Medical University, The First Affiliated Hospital of Nanchang University
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 600 participants through statistic calculation. The plan for missing data and statistical analysis will be implemented by specialized statisticians of China Medical University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: Saline |
| Heparin | Experimental | Drug: Heparin Sodium, Drug: SalineIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin SodiumAlso: Unfractionated heparinA 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. | Drug | Heparin |
| SalineAlso: Normal salineFor all the severe sepsis or septic shock patients, normal saline will be administered for fluid resuscitation according to the Guideline of Survival Sepsis Campaign. | Drug | Heparin, Saline |
Primary outcome
ICU mortality
Time frame: during ICU stay (up to day 28)
The mortality during ICU stay
2 secondary outcomes
28-day all-cause mortality
Time frame: after 28 days of enrollment of all the cases
the incidence of major bleeding
Time frame: during ICU stay (up to day 28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 17147870Zhang 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.
- Background: PubMed 19957797Zhao 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.
- Background: PubMed 19242322Jaimes 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.
- Background: PubMed 24520253Liu 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.
- Background: PubMed 14680357Barkun 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.
- Derived from this study: PubMed 38167115Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin Sodium and Saline in people with Sepsis and Disseminated Intravascular Coagulation, run by China Medical University, China at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaochun Ma, M.D. (0086-13840192939, maxc_cmu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: during ICU stay (up to day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654561, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.