drugset / Trial / NCT02654561
Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation
Phase 3
Unknown
600 enrolled
China Medical University, China
Beijing Friendship Hospital · collabBeijing Tsinghua Changgeng Hospital · collabFirst Affiliated Hospital of Harbin Medical University · collabFirst Affiliated Hospital of Kunming Medical University · collabFourth People's Hospital of Shenyang · collabGeneral Hospital of Ningxia Medical University · collabPeking University People's Hospital · collabQilu Hospital of Shandong University · collabShengjing Hospital · collabThe Affiliated Hospital of Qingdao University · collabThe First Affiliated Hospital of Dalian Medical University · collabThe First Affiliated Hospital of Nanchang University · collabThe First Hospital of Jilin University · collabThe First Hospital of Qinhuangdao · collabThe People's Hospital of Liaoning Province · collabThe Second Affiliated Hospital of Dalian Medical University · collabThe Second Affiliated Hospital of Kunming Medical University · collabWest China Hospital · collabZhongda Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-04-12
- Primary completion
- 2024-12
- Completion
- 2025-06
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Heparin | Other / unclassified | 12500 iu | Intravenous |