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| Name | Class |
|---|---|
| West China Hospital | OTHER |
| Zhongda Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Shengjing Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin Sodium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | The mortality during ICU stay | during ICU stay (up to day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality | The all-cause mortality at day 28 after enrollment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in JAAM and ISTH scores | The difference of JAAM and ISTH scores between day7 and day1 upon enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaochun Ma, M.D. | Contact | 0086-13840192939 | maxc_cmu@sina.com | |
| Yini Sun, Ph.D | Contact | 0086-13700017130 | sunyini_1006@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The fist Affiliated Hospital Harbin Medical University | Recruiting | Haerbin | Heilongjiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17147870 | Background | 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. | |
| 19957797 | Background | 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. |
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| 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 |
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|
|
| Saline | Drug | 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. |
|
|
| during ICU stay (up to day 28) |
| during the intervention period (up to day 7 upon enrollment) |
| Xiangya Third Hospital of Central South University | Recruiting | Changsha | Hunan | China |
|
| Zhongda Hospital | Recruiting | Nanjing | Jiangsu | China |
|
| First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | China |
|
| Second Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | China |
|
| second Affiliated Hospital of china Medical University | Recruiting | Shenyang | Liaoning | China |
|
| Shenyang Fourth People's Hospital | Recruiting | Shenyang | Liaoning | China |
|
| Qilu Hospital of Shandong University（qingdao） | Recruiting | Qingdao | Shandong | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
|
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | China |
|
| the Second Affiliated Hospital of Kunming University | Recruiting | Kunming | Yunnan | China |
|
| Beijing Friendship Hospital ， Capital Medical University | Recruiting | Beijing | China |
|
| Changgeng Hospital of Tsinghua University | Recruiting | Beijing | China |
|
| People's Hospital of Peking University | Recruiting | Beijing | China |
|
| First Affiliated Hospital of Jilin Medical University | Recruiting | Jilin City | China |
|
| Qinhuangdao First Hospital | Recruiting | Qinhuangdao | China |
|
| Liaoning Provincial People's Hospital | Recruiting | Shenyang | China |
|
| 19242322 | Background | 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. |
| 24520253 | Background | 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. |
| 14680357 | Background | 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. |
| 38167115 | Derived | 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. |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004211 | Disseminated Intravascular Coagulation |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D019851 | Thrombophilia |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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