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Not yet recruitingNCT06078839NMSICRCTUpdated Oct 12, 2023

Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

A Phase 4 interventional study of Nafamostat mesilate and 5% glucose in Sepsis, Sepsis-induced Coagulopathy and Nafamostat Mesilate, sponsored by Xu Li. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Xu Li · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
778
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Sepsis
  • Sepsis-induced Coagulopathy
  • Nafamostat Mesilate
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 778 is above the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

This is the only study on the registry with Xu Li as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
778 participants (estimated)

Study arms

  • Placebo comparator
    Placebo control group

    Drug: 5% glucose

  • Experimental
    Nafamostat mesilate treatment group (experimental group)

    Drug: Nafamostat mesilate

Interventions

  • DrugNafamostat mesilate

    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)

  • Drug5% glucose

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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06078839
Lead 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 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
Responsible party
Xu Li (Professor, First Hospital of China Medical University) — Sponsor-investigator
First posted
Oct 12, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Oct 12, 2023

Study contacts

Xu Li, Phd
Contact
vincentzh002@outlook.com
+8613604059359
Xu Li, Phd
principal investigator · First Hospital of China Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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