Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

• Status: Not yet recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xu Li
• Collaborators: 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 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
• Treatments: Nafamostat

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