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Not yet recruiting NCT06994312

The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration

No phase Interventional Sepsis-induced Coagulopathy (SIC)

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 Mesylate, sodium citrate.
Who it may be relevant to
Registry conditions: Sepsis-induced Coagulopathy (SIC). Basic parameters: from 18 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 →

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Official title

The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration：A Single-Center, Prospective, Randomized Controlled Trial

Overview

In sepsis, the body is prone to coagulation system disorders, which may progress to sepsis-induced coagulopathy (SIC). When SIC is persistent and cannot be corrected, it often sequentially develops into disseminated intravascular coagulation (DIC) with multiple organ failure. Nafamostat mesylate can be used as an anticoagulant during blood purification in critically ill patients and is also used to treat SIC.Safe and effective anticoagulation is a prerequisite for the success of blood purification therapy. For patients with active bleeding or at risk of bleeding, how to achieve extracorporeal anticoagulation without affecting the body's coagulation function is a major clinical challenge. Nafamostat mesylate can reduce the risk of bleeding during blood purification, but its impact on the survival outcomes of patients with SIC undergoing blood purification therapy remains unclear.The aim of this study is to evaluate the impact of nafamostat mesylate treatment on the prognosis of patients with sepsis-induced coagulopathy undergoing hemofiltration.

Interventions

  • Drug Nafamostat Mesylate
    Anticoagulation with Nafamostat Mesylate for SIC Patients Undergoing Hemofiltration
  • Drug sodium citrate
    Anticoagulation with Sodium Citrate for SIC Patients Undergoing Hemofiltration

Primary outcome measures

  • ICU Mortality Rates [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (4)
  • Average Filter Lifespan [Time frame: Through study completion, an average of 1 year]
  • ICU length of stay [Time frame: Through study completion, an average of 1 year]
  • 28-day mortality [Time frame: Through study completion, an average of 1 year]
  • Incidence of Bleeding [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Adults (Age ≥ 18 years);
  • Patients with SIC Undergoing Hemofiltration.

Exclusion criteria

  • Individuals under the age of 18, pregnant women, and breastfeeding mothers;
  • Patients with a history of high sensitivity to nafamostat mesylate (those who have experienced significant bleeding complications from previous use of nafamostat mesylate);
  • Fibrinogen < 1.5 g/L;
  • Patients with bleeding or high risk of bleeding:

Those in the acute phase of trauma or with active bleeding (e.g., flail chest, obvious contusions of the lungs, liver, spleen, retroperitoneal bleeding, pelvic fractures, etc.); Those with a history of severe head trauma, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within one month prior to enrollment; Those with a history of congenital bleeding disorders: such as hemophilia; Those with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases.

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
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06994312 · Yuting Li 20250430

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗