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

Xu Li

Status and phase

Not yet enrolling

Phase 4

Conditions

Nafamostat Mesilate

Sepsis-induced Coagulopathy

Sepsis

Treatments

Drug: 5% glucose

Drug: Nafamostat mesilate

Study type

Interventional

Funder types

Other

Identifiers

NCT06078839

AF-0G-03-1.1-02

Details and patient eligibility

About

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

Enrollment

778 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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