Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

778 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-10-01

Brief Summary

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

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Detailed Description

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Conditions

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Sepsis Sepsis-induced Coagulopathy Nafamostat Mesilate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Nafamostat mesilate treatment group (experimental group) : Basic treatment + Nafamostat mesilate 2.0 mg/kg/d Placebo control group: Basic treatment + 5% glucose with Nafamostat mesilate equal volume

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo control group

Group Type PLACEBO_COMPARATOR

5% glucose

Intervention Type DRUG

Add 50ml of 5% glucose into a 50ml syringe

Nafamostat mesilate treatment group (experimental group)

Group Type EXPERIMENTAL

Nafamostat mesilate

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

5% glucose

Add 50ml of 5% glucose into a 50ml syringe

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No