Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02654561
Other study ID # LNCCC-B01-2014
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 12, 2018
Est. completion date June 2025

Study information

Verified date November 2023
Source China Medical University, China
Contact Xiaochun Ma, M.D.
Phone 0086-13840192939
Email maxc_cmu@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The third one is to evaluate the safety of UFH in severe sepsis patients with suspected DIC.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China Beijing Friendship Hospital , Capital Medical University Beijing
China Changgeng Hospital of Tsinghua University Beijing
China People's Hospital of Peking University Beijing
China Xiangya Third Hospital of Central South University Changsha Hunan
China West China Hospital of Sichuan University Chengdu Sichuan
China First Affiliated Hospital of Dalian Medical University Dalian Liaoning
China Second Affiliated Hospital of Dalian Medical University Dalian Liaoning
China The fist Affiliated Hospital Harbin Medical University Haerbin Heilongjiang
China First Affiliated Hospital of Jilin Medical University Jilin
China First Affiliated Hospital of Kunming Medical University Kunming Yunnan
China the Second Affiliated Hospital of Kunming University Kunming Yunnan
China Zhongda Hospital Nanjing Jiangsu
China Qilu Hospital of Shandong University(qingdao) Qingdao Shandong
China Qinhuangdao First Hospital Qinhuangdao
China Liaoning Provincial People's Hospital Shenyang
China second Affiliated Hospital of china Medical University Shenyang Liaoning
China Shenyang Fourth People's Hospital Shenyang Liaoning

Sponsors (20)

Lead Sponsor Collaborator
China Medical University, China Beijing Friendship Hospital, Beijing Tsinghua Changgeng Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Kunming Medical University, Fourth People's Hospital of Shenyang, General Hospital of Ningxia Medical University, Peking University People's Hospital, Qilu Hospital of Shandong University, Shengjing Hospital, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Nanchang University, The First Hospital of Jilin University, The First Hospital of Qinhuangdao, The People's Hospital of Liaoning Province, The Second Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Kunming Medical University, West China Hospital, Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in SOFA scores The difference of SOFA scores between day 7 and day 1 upon enrollment during the intervention period (up to day 7 after enrollment)
Other Change in JAAM and ISTH scores The difference of JAAM and ISTH scores between day7 and day1 upon enrollment during the intervention period (up to day 7 upon enrollment)
Primary ICU mortality The mortality during ICU stay during ICU stay (up to day 28)
Secondary 28-day all-cause mortality The all-cause mortality at day 28 after enrollment after 28 days of enrollment of all the cases
Secondary 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 during ICU stay (up to day 28)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3