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NCT Number: NCT06994312

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

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.

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Key information

Conditions

Sepsis-induced Coagulopathy (SIC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nafamostat Mesylate

Drug

Anticoagulation with Nafamostat Mesylate for SIC Patients Undergoing Hemofiltration

Other names: Experimental Group

sodium citrate

Drug

Anticoagulation with Sodium Citrate for SIC Patients Undergoing Hemofiltration

Other names: Control Group

Primary outcomes

ICU Mortality Rates

Time frame: Through study completion, an average of 1 year

The proportion of patients who died during the ICU stay out of the total number of patients in the group.

Secondary outcomes

Average Filter Lifespan

Time frame: Through study completion, an average of 1 year

The total sum of all filter usage times for each patient divided by the number of filters used.
ICU length of stay

Time frame: Through study completion, an average of 1 year

Length of Stay in the ICU
28-day mortality

Time frame: Through study completion, an average of 1 year

The proportion of patients who died within 28 days out of the total number of patients in the group.
Incidence of Bleeding

Time frame: Through study completion, an average of 1 year

The proportion of patients experiencing bleeding events (such as cerebral hemorrhage, gastrointestinal bleeding, etc.) during the ICU stay out of the total number of patients.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: May 29, 2025
Registry last updated: May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.