Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy (NMSICRCT)

Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy: a Multicenter Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Sepsis-induced Coagulopathy; Nafamostat Mesilate
• Intervention / Treatment: Drug: 5% glucose; Drug: Nafamostat mesilate

• Study Type: Interventional
• Enrollment (Estimated): 778
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xu Li, Phd; Phone Number: +8613604059359; Email: vincentzh002@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control group	Drug: 5% glucose; Add 50ml of 5% glucose into a 50ml syringe
Experimental: Nafamostat mesilate treatment group (experimental group)	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality in ICU	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xu Li
• Collaborators: LanZhou University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Tianjin Medical University General Hospital; Northern Jiangsu Province People's Hospital; Tianjin Third Central Hospital; Zhejiang Provincial People's Hospital; First Affiliated Hospital of Xinjiang Medical University; The Affiliated Hospital of Nantong University; Shanxi Provincial People's Hospital; Huludao central hospital; Hohhot First Hospital; The Sixth People's Hospital of Shenyang; Shanxi Bethune Hospital; The First Affiliated Hospital of Gannan Medical University; The Second Hospital University of South China; Zhejiang Hospital; Benxi Cental Hospital; The Jiangxi Provincial People's Hospital; The First Bethune Hospital Jilin University; The First Affiliated Hospital of Suzhou Medical; Anhui Provincial Hospita; The First Affiliated Hospital of Ningbo; The First Affiliated Hospital of Wenzhou; The Second Affiliated Hospital Xi'an Jiaotong; The First Affiliated Hospital of Xinjiang; Tongji Medical College of Huazhong University; The Fourth Affiliated Hospital of China Medical; The First Affiliated Hospital of Liaoning; Genertec Liaoyou Gem Flower Hospital; The Tenth People's Hospital of Shenyang; Dalian NO.3 People's Hospital; Liaoyang City Central Hospital
• Investigators: Principal Investigator: Xu Li, Phd, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Hemorrhagic Disorders; Sepsis; Toxemia; Hemostatic Disorders; Blood Coagulation Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Protease Inhibitors; Serine Proteinase Inhibitors; Anticoagulants; Trypsin Inhibitors; Complement Inactivating Agents; Nafamostat
• Other Study ID Numbers: AF-0G-03-1.1-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No