NCT05874674

Brief Summary

Comparison nafamostat and low molecular weight heparin among dialysis patients

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

April 18, 2023

Last Update Submit

July 28, 2024

Conditions

Dialysis; ComplicationsBleeding

Keywords

dialysisbleedingnafamostatheaprin

Outcome Measures

Primary Outcomes (1)

  • Number of patients with severe bleeding

    Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD)

    6 month

Secondary Outcomes (1)

  • Number of patients with dialysis circuit clot

    6 month

Study Arms (2)

nafamostat

ACTIVE COMPARATOR

Patients received dialysis through nafamostat

Drug: Nafamostat Mesylate

Cnoxane

NO INTERVENTION

Patients received dialysis through cnoxan

Interventions

Nafamostat MesylateDRUG

Comparison effect of nafamostat and cnoxan

Also known as: cnoxan
nafamostat

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • platelet below 10k PTT above 60 second INR above 20 patient with bleeding (epistaxis, orbital bleeding, hematuria) recent brain hemorrhage (within 6 months) receiving anticoagulant therapy (coumadin or NOAC) dual antiplatelet agent users received major surgery within one month

You may not qualify if:

  • cancer liver cirrhosis pregnancy drug allergy current bleeding on major organ (brain, gastrointestinal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Unviersity Wonju College of Medicin

Wŏnju, Kangwondo, 26426, South Korea

RECRUITING

Related Publications (1)

  • Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

    PMID: 38189593DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

nafamostat

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 25, 2023

Study Start

December 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)