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

Primary Purpose

Sepsis, Sepsis-induced Coagulopathy, Nafamostat Mesilate

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nafamostat mesilate
5% glucose
Sponsored by
Xu Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo control group

    Nafamostat mesilate treatment group (experimental group)

    Arm Description

    Outcomes

    Primary Outcome Measures

    All-cause mortality in ICU

    Secondary Outcome Measures

    Improvement in organ function (SOFA score)
    DIC score (JAAM/ISTH score) changes;
    28-day all-cause fatality rate
    Adverse event rate

    Full Information

    First Posted
    September 20, 2023
    Last Updated
    October 5, 2023
    Sponsor
    Xu Li
    Collaborators
    Tianjin Third Central Hospital, Tianjin Medical University General Hospital, Shanxi Provincial People's Hospital, Shanxi Bethune Hospital, Hohhot First Hospital, The First Bethune Hospital Jilin University, Northern Jiangsu Province 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, The 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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06078839
    Brief Title
    Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy
    Acronym
    NMSICRCT
    Official Title
    Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy: a Multicenter Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2026 (Anticipated)
    Study Completion Date
    October 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xu Li
    Collaborators
    Tianjin Third Central Hospital, Tianjin Medical University General Hospital, Shanxi Provincial People's Hospital, Shanxi Bethune Hospital, Hohhot First Hospital, The First Bethune Hospital Jilin University, Northern Jiangsu Province 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, The 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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis, Sepsis-induced Coagulopathy, Nafamostat Mesilate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    778 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo control group
    Arm Type
    Placebo Comparator
    Arm Title
    Nafamostat mesilate treatment group (experimental group)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Nafamostat mesilate
    Intervention Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    5% glucose
    Intervention Description
    Add 50ml of 5% glucose into a 50ml syringe
    Primary Outcome Measure Information:
    Title
    All-cause mortality in ICU
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Improvement in organ function (SOFA score)
    Time Frame
    7 days
    Title
    DIC score (JAAM/ISTH score) changes;
    Time Frame
    7 days
    Title
    28-day all-cause fatality rate
    Time Frame
    28-day
    Title
    Adverse event rate
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xu Li, Phd
    Phone
    +8613604059359
    Email
    vincentzh002@outlook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xu Li, Phd
    Organizational Affiliation
    First Hospital of China Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

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