Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

Sepsis Clinical Trial

— NMSICRCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06078839
• Other study ID #: AF-0G-03-1.1-02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: October 2023
• Source: First Hospital of China Medical University
• Contact: Xu Li, Phd
• Phone: +8613604059359
• Email: vincentzh002[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 778
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (33)

Lead Sponsor

Collaborator

Xu Li

Anhui Provincial Hospita, Benxi Cental Hospital, Dalian NO.3 People's Hospital, First Affiliated Hospital of Xinjiang Medical University, Genertec Liaoyou Gem Flower Hospital, Hohhot First Hospital, Huludao central hospital, LanZhou University, Liaoyang City Central Hospital, Northern Jiangsu Province People's Hospital, Shanxi Bethune Hospital, Shanxi Provincial 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 Gannan Medical University, The First Affiliated Hospital of Liaoning, The First Affiliated Hospital of Ningbo, The First Affiliated Hospital of Suzhou Medical, The First Affiliated Hospital of Wenzhou, The First Affiliated Hospital of Xinjiang, The First Bethune Hospital Jilin University, The Fourth Affiliated Hospital of China Medical, The Jiangxi Provincial People's Hospital, The Second Affiliated Hospital Xi'an Jiaotong, The Second Hospital University of South China, The Sixth People's Hospital of Shenyang, The Tenth People's Hospital of Shenyang, Tianjin Medical University General Hospital, Tianjin Third Central Hospital, Tongji Medical College of Huazhong University, Zhejiang Hospital, Zhejiang Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality in ICU		7 days
Secondary	Improvement in organ function (SOFA score)		7 days
Secondary	DIC score (JAAM/ISTH score) changes;		7 days
Secondary	28-day all-cause fatality rate		28-day
Secondary	Adverse event rate		7 days