Clinical trial NCT06994312: The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sepsis-induced Coagulopathy (SIC)
Keywords: Single-Center, Prospective, Randomized Controlled Trial
sepsis-induced coagulopathy (SIC)
Nafamostat Mesylate
Prognosis
Hemofiltration
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: ICU Mortality Rates
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Average Filter Lifespan
timeFrame: Through study completion, an average of 1 year
measure: ICU length of stay
timeFrame: Through study completion, an average of 1 year
measure: 28-day mortality
timeFrame: Through study completion, an average of 1 year
measure: Incidence of Bleeding
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References: