PMID- 38167115
OWN - NLM
STAT- MEDLINE
DCOM- 20240105
LR  - 20240106
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 25
IP  - 1
DP  - 2024 Jan 2
TI  - Efficacy and safety of heparin for sepsis-induced disseminated intravascular 
      coagulation (HepSIC): study protocol for a multicenter randomized controlled 
      trial.
PG  - 4
LID - 10.1186/s13063-023-07853-5 [doi]
LID - 4
AB  - BACKGROUND: Disseminated intravascular coagulation (DIC) occurs in 30-50% of 
      septic patients and contributes to high mortality in the intensive care unit 
      (ICU). However, there are few proven interventions for coagulation disorder 
      management in sepsis. Experimental and clinical data have demonstrated that 
      sepsis could benefit from unfractionated heparin (UFH) treatment. To date, there 
      are no large multicenter trials to determine the safety and efficacy of UFH in 
      septic patients with suspected DIC. METHODS: A multicenter, double-blinded, 
      placebo-controlled randomized trial is designed to recruit 600 patients who met 
      sepsis 3.0 criteria and suspected DIC. Participants will be randomized (1:1) to 
      receive UFH or saline via continuous intravenous administration for 7 days within 
      6 h of enrolment. The primary outcome is ICU mortality. The secondary outcome 
      includes 28-day all-cause mortality, the improvement of Sequential Organ Failure 
      Assessment scores, and the incidence of major hemorrhage. Investigators, 
      participants, and statisticians will be blinded to the allocation. DISCUSSION: 
      The HepSIC trial is to evaluate the efficacy and safety of UFH on sepsis-related 
      DIC across different areas of China. The small dosage of UFH administration would 
      offer a new potential approach for treating sepsis-related coagulation disorders. 
      ETHICS AND DISSEMINATION: Ethical approval was granted by all the ethics 
      committees of 20 participant centers. Results will be disseminated via 
      peer-reviewed publications and presented at conferences. TRIAL REGISTRATION: 
      ClinicalTrials.gov NCT02654561. Registered on 13 January 2016.
CI  - (c) 2023. The Author(s).
FAU - Sun, Yini
AU  - Sun Y
AD  - Department of Critical Care Medicine, The First Affiliated Hospital of China 
      Medical University, Shenyang, China.
FAU - Ding, Renyu
AU  - Ding R
AD  - Department of Critical Care Medicine, The First Affiliated Hospital of China 
      Medical University, Shenyang, China.
FAU - Sun, Hao
AU  - Sun H
AD  - Department of Clinical Epidemiology and Evidence-based Medicine, The First 
      Affiliated Hospital of China Medical University, Shenyang, China.
FAU - Liang, Yingjian
AU  - Liang Y
AD  - Department of Critical Care Medicine, The First Affiliated Hospital of China 
      Medical University, Shenyang, China.
FAU - Ma, Xiaochun
AU  - Ma X
AUID- ORCID: 0000-0002-1714-9800
AD  - Department of Critical Care Medicine, The First Affiliated Hospital of China 
      Medical University, Shenyang, China. maxc_cmu@sina.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02654561
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20240102
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Humans
MH  - Heparin/adverse effects
MH  - *Disseminated Intravascular Coagulation/diagnosis/drug therapy/etiology
MH  - *Sepsis/complications/diagnosis/drug therapy
MH  - *Blood Coagulation Disorders/drug therapy
MH  - Hemorrhage/drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
PMC - PMC10759642
OTO - NOTNLM
OT  - Disseminated intravascular coagulation
OT  - Heparin
OT  - Randomized controlled trial
OT  - Sepsis
COIS- The authors declare that they have no competing interests.
EDAT- 2024/01/04 01:18
MHDA- 2024/01/05 06:43
PMCR- 2024/01/02
CRDT- 2024/01/03 09:32
PHST- 2023/08/15 00:00 [received]
PHST- 2023/12/06 00:00 [accepted]
PHST- 2024/01/05 06:43 [medline]
PHST- 2024/01/04 01:18 [pubmed]
PHST- 2024/01/03 09:32 [entrez]
PHST- 2024/01/02 00:00 [pmc-release]
AID - 10.1186/s13063-023-07853-5 [pii]
AID - 7853 [pii]
AID - 10.1186/s13063-023-07853-5 [doi]
PST - epublish
SO  - Trials. 2024 Jan 2;25(1):4. doi: 10.1186/s13063-023-07853-5.