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ArticleTrials2025

Efficacy and safety of nafamostat mesilate for sepsis (EASNMS): study protocol for a multicenter randomized controlled trial.

Hongyu Yang, Jianshuang Feng, Yuteng Ma, Xiaochun Ma, Xu Li, EASNMS investigators

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06078839 (Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06078839 phase4not yet recruitingnot on this map

Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy: a Multicenter Randomized Controlled Trial

TypeinterventionalSponsorXu LiRan2023 to 2026Enrolled778ConditionsSepsis, Sepsis-induced Coagulopathy, Nafamostat MesilateArmsNafamostat mesilate, 5% glucose
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Hongyu YangDepartment of Critical Care Medicine, The First Affiliated Hospital of China Medical University, North Nanjing Street 155, Shenyang, Liaoning Province, 110001, People's Republic of China.
Jianshuang FengDepartment of Critical Care Medicine, The First Affiliated Hospital of China Medical University, North Nanjing Street 155, Shenyang, Liaoning Province, 110001, People's Republic of China.
Yuteng MaDepartment of Gastrointestinal Surgery, The First Affiliated Hospital of China Medical University, North Nanjing Street 155, Shenyang, Liaoning Province, 110001, People's Republic of China.
Xiaochun MaDepartment of Critical Care Medicine, The First Affiliated Hospital of China Medical University, North Nanjing Street 155, Shenyang, Liaoning Province, 110001, People's Republic of China.
Xu LiDepartment of Critical Care Medicine, The First Affiliated Hospital of China Medical University, North Nanjing Street 155, Shenyang, Liaoning Province, 110001, People's Republic of China. vincentzh002@outlook.com.
EASNMS investigators

Funding

National Key R&D Program of China 2022YFC2304605
6 · The paper itself

Abstract

backgroundSepsis is the leading cause of death in critically ill patients, with an in-hospital mortality rate of approximately 25% to 40%. Coagulation activation serves as an initial factor to the progression of sepsis into multiple organ dysfunction syndrome (MODS). Therefore, anticoagulant therapy may be beneficial. Both preclinical experiments and clinical studies have evaluated the protective effect of nafamostat mesilate (NM) in sepsis. However, there is still a lack of randomized controlled trials (RCTs) to further confirm the therapeutic effect and safety of NM in sepsis patients.

methodsThis multicenter, double-blind, RCT was designed to recruit 778 subjects who met Sepsis 3.0 criteria. Participants will be randomly assigned (1:1) to receive either intravenous administration of NM or glucose along with standard treatment. The primary outcome is the all-cause mortality rate in the intensive care unit (ICU), and the secondary outcomes include the improvement in SOFA scores, changes in Japanese Association for Acute Medicine (JAAM)/International Society on Thrombosis and Hemostasis (ISTH) scores, 28-day all-cause mortality rate, and the incidence of adverse events. The allocation will remain concealed from investigators, participants, and statisticians to maintain blinding. DISCUSSION: The EASNMS trial aims to assess the efficacy and safety of NM for treating sepsis across various regions in China. As an additional treatment option, NM may potentially enhance the prognosis of sepsis patients. ETHICS AND DISSEMINATION: Ethical approval has been obtained from all ethics committees of the involved centers. The findings of this study will be shared in peer-reviewed journals and will be presented at conferences.

trial registrationClinicalTrials.gov NCT06078839. Registered on September 20, 2023.

Indexed as

AnticoagulantsBenzamidinesGuanidinesSepsisAdultDouble-Blind MethodFemaleHospital MortalityHumansMaleMiddle AgedMulticenter Studies as TopicMultiple Organ FailureOrgan Dysfunction ScoresRandomized Controlled Trials as TopicTreatment OutcomeAnticoagulantsBenzamidinesGuanidinesnafamostatCoagulation activationNafamostat mesilateSepsis

Identifiers

PMID40731293
PMCPMC12309187

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.