Status:
NOT_YET_RECRUITING
Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy
Lead Sponsor:
Xu Li
Collaborating Sponsors:
Tianjin Third Central Hospital
Tianjin Medical University General Hospital
Conditions:
Sepsis
Sepsis-induced Coagulopathy
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
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
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
778 Patients enrolled
Trial Details
Trial ID
NCT06078839
Start Date
October 1 2023
End Date
October 1 2026
Last Update
October 12 2023
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