Clinical trial NCT06078839: Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy
Official title: Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Sepsis
Sepsis-induced Coagulopathy
Nafamostat Mesilate
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Third Central Hospital
name: Tianjin Medical University General Hospital
name: Shanxi Provincial People's Hospital
name: Shanxi Bethune Hospital
name: Hohhot First Hospital
name: The First Bethune Hospital Jilin University
name: Northern Jiangsu People's Hospital
name: The Affiliated Hospital of Nantong University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The First Affiliated Hospital of Suzhou Medical
name: Anhui Provincial Hospita
name: Zhejiang Hospital
name: Zhejiang Provincial People's Hospital
name: The First Affiliated Hospital of Ningbo
name: The First Affiliated Hospital of Wenzhou
name: The Jiangxi Provincial People's Hospital
name: First Affiliated Hospital of Gannan Medical University
name: The Second Affiliated Hospital Xi'an Jiaotong
name: LanZhou University
name: The First Affiliated Hospital of Xinjiang
name: First Affiliated Hospital of Xinjiang Medical University
name: Tongji Medical College of Huazhong University
name: The Second Hospital University of South China
name: The Fourth Affiliated Hospital of China Medical
name: The First Affiliated Hospital of Liaoning
name: Genertec Liaoyou Gem Flower Hospital
name: The Tenth People's Hospital of Shenyang
name: The Sixth People's Hospital of Shenyang
name: Dalian NO.3 People's Hospital
name: Benxi Cental Hospital
name: Liaoyang City Central Hospital
name: Huludao central hospital
First posted: 2023-10-12
Enrollment: 778
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality in ICU
timeFrame: 7 days
Secondary outcomes:
measure: Improvement in organ function (SOFA score)
timeFrame: 7 days
measure: DIC score (JAAM/ISTH score) changes;
timeFrame: 7 days
measure: 28-day all-cause fatality rate
timeFrame: 28-day
measure: Adverse event rate
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: First Hospital of China Medical University
name: Xu Li, Phd
role: PRINCIPAL_INVESTIGATOR
References: