Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

Phase 4

Not yet recruiting

• Conditions: Sepsis-induced Coagulopathy; Nafamostat Mesilate; Sepsis
• Interventions: Drug: Nafamostat mesilate; Drug: 5% glucose

• Registration Number: NCT06078839
• Lead Sponsor: Xu Li

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-05
• Last Update Submitted: 2023-10-05
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 778

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/）

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nafamostat mesilate treatment group (experimental group)	Nafamostat mesilate	-
Placebo control group	5% glucose	-

Primary Outcome Measures

Name	Time	Method
All-cause mortality in ICU	7 days

Secondary Outcome Measures

Name	Time	Method
DIC score (JAAM/ISTH score) changes;	7 days
Improvement in organ function (SOFA score)	7 days
Adverse event rate	7 days
28-day all-cause fatality rate	28-day