Sepsis, Sepsis-induced Coagulopathy, Nafamostat Mesilate
Conditions
Brief summary
The objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。
Interventions
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)
DRUG5% glucose
Add 50ml of 5% glucose into a 50ml syringe
Sponsors
Tianjin Third Central Hospital
Tianjin Medical University General Hospital
Shanxi Provincial People's Hospital
Shanxi Bethune Hospital
Hohhot First Hospital
Jilin University
Northern Jiangsu People's Hospital
The Affiliated Hospital of Nantong University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Suzhou Medical
Anhui Provincial Hospita
Zhejiang Hospital
Zhejiang Provincial People's Hospital
The First Affiliated Hospital of Ningbo
The First Affiliated Hospital of Wenzhou
The Jiangxi Provincial People's Hospital
First Affiliated Hospital of Gannan Medical University
The Second Affiliated Hospital Xi'an Jiaotong
LanZhou University
The First Affiliated Hospital of Xinjiang
First Affiliated Hospital of Xinjiang Medical University
Tongji Medical College of Huazhong University
The Second Hospital University of South China
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
The Sixth People's Hospital of Shenyang
Dalian NO.3 People's Hospital
Benxi Cental Hospital
Liaoyang City Central Hospital
Huludao central hospital
Xu Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality in ICU | 7 days |
Secondary
| 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 |
Contacts
Primary ContactXu Li, Phd
Outcome results
None listed