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Not yet recruiting NCT06078839

Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

Phase IV Interventional Sepsis Sepsis-induced Coagulopathy Nafamostat Mesilate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nafamostat mesilate, 5% glucose.
Who it may be relevant to
Registry conditions: Sepsis, Sepsis-induced Coagulopathy, Nafamostat Mesilate. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。

Interventions

  • Drug Nafamostat mesilate
    Nafamostat mesilate treatment group was dissolved with 5% glucose at the dosage of 2.0mg/kg/ day to a total of 50ml(Maximum concentration 10mg/ml)
  • Drug 5% glucose
    Add 50ml of 5% glucose into a 50ml syringe

Primary outcome measures

  • All-cause mortality in ICU [Time frame: 7 days]
Secondary outcome measures (4)
  • Improvement in organ function (SOFA score) [Time frame: 7 days]
  • DIC score (JAAM/ISTH score) changes; [Time frame: 7 days]
  • 28-day all-cause fatality rate [Time frame: 28-day]
  • Adverse event rate [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • meets the criteria for sepsis 3.0".
  • Targeted population for SIC anticoagulant therapy（http://research-kudo-prediction.s3-website-ap-northeast-1.amazonaws.com/）

Exclusion criteria

  • Age less than 18, pregnant women, and lactating women
  • Patients with a history of hypersensitivity to nafamostat mesilate (previous use of nafamostat mesilate resulted in significant bleeding complications)
  • Fibrinogen < 1.5g/L
  • Patients with bleeding or high bleeding risk Patients in the acute phase of trauma or with active bleeding (such as flail chest, significant contusions of the lungs, liver, kidneys, spleen, retroperitoneal bleeding, pelvic fractures, etc.) History of severe traumatic brain injury, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within the past month prior to enrollment Patients with a history of congenital bleeding disorders (such as hemophilia) Patients with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases
  • Patients receiving the following medications Patients who have received heparin and heparin analogs (including low molecular weight heparin, dalteparin, etc.) within the past 12 hours prior to treatment Patients who have received warfarin within the past 7 days prior to the study and have an INR level above normal Patients who have undergone thrombolytic therapy within the past 3 days prior to the study Patients who have received platelet inhibitors (such as aspirin, clopidogrel, ticlopidine, dipyridamole, etc.) within the past 7 days prior to the study Patients currently receiving other novel anticoagulant medications (such as Xa factor inhibitors like apixaban, rivaroxaban, edoxaban, etc., direct thrombin inhibitors like dabigatran
  • ICU treatment time is expected to be no more than 24h
  • Patients who have undergone cardiopulmonary resuscitation within the past 7 days prior to the study
  • Patients who have participated in other studies within the 30 days prior to enrollment
  • Due to irreversible disease states, such as advanced malignant tumors or other end-stage diseases; or patients in a terminal state deemed by the physician to be approaching death

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Yang H, Feng J, Ma Y, Ma X, Li X; EASNMS investigators. Efficacy and safety of nafamostat mesilate for sepsis (EASNMS): study protocol for a multicenter randomized controlled trial. Trials. 2025 Jul 29;26(1):262. doi: 10.1186/s13063-025-08979-4. PMID 40731293

Identifiers

NCT: NCT06078839 · AF-0G-03-1.1-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗