Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06078839

Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nafamostat Mesilate

Drug

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

Drug

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

Primary outcomes

  1. All-cause mortality in ICU

    Time frame: 7 days

Secondary outcomes

  1. Improvement in organ function (SOFA score)

    Time frame: 7 days

  2. DIC score (JAAM/ISTH score) changes;

    Time frame: 7 days

  3. 28-day all-cause fatality rate

    Time frame: 28-day

  4. Adverse event rate

    Time frame: 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Xu Li, Phd

CONTACT

[email protected]

+8613604059359

Sponsors and collaborators

Lead sponsor

Xu Li

Other

Collaborators

  • Affiliated Hospital of Nantong University
  • Anhui Provincial Hospital
  • Benxi Cental Hospital
  • Dalian NO.3 People's Hospital
  • First Affiliated Hospital of Gannan Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • Genertec Liaoyou Gem Flower Hospital
  • Hohhot First Hospital
  • Huludao central hospital
  • Jiangxi Provincial People's Hopital
  • Jilin University
  • LanZhou University
  • Liaoyang City Central Hospital
  • Northern Jiangsu People's Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Shanxi Bethune Hospital
  • Shanxi Provincial People's Hospital
  • Shenyang Sixth People's Hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • 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 Fourth Affiliated Hospital of China Medical
  • The Second Hospital University of South China
  • 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

Registry information

Official study title

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

Acronym: NMSICRCT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.