Evaluating Nafamostat Mesylate for Dialysis Patients at High Risk of Bleeding
The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Diathesis Undergoing Hemodialysis: A Pilot Study
NA · Wonju Severance Christian Hospital · NCT05874674
This study is testing if Nafamostat Mesylate can be a safer blood thinner than heparin for dialysis patients who are at high risk of bleeding.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Wonju Severance Christian Hospital (other) |
| Locations | 1 site (Wŏnju, Kangwondo) |
| Trial ID | NCT05874674 on ClinicalTrials.gov |
What this trial studies
This pilot study compares the safety and efficacy of Nafamostat Mesylate to low molecular weight heparin in patients undergoing hemodialysis who are at high risk for bleeding complications. The study aims to determine whether Nafamostat can provide a safer alternative for anticoagulation in this vulnerable population. Participants will be monitored for bleeding events and other complications during the treatment period. The study focuses on patients with specific bleeding risks, including those with low platelet counts and recent major surgeries.
Who should consider this trial
Good fit: Ideal candidates include dialysis patients with significant bleeding risks, such as low platelet counts and recent major surgeries.
Not a fit: Patients with active bleeding in major organs, cancer, liver cirrhosis, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anticoagulation options for dialysis patients at high risk of bleeding.
How similar studies have performed: While there is limited data on Nafamostat specifically in this context, similar studies have explored alternative anticoagulants in high-risk populations with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * cancer liver cirrhosis pregnancy drug allergy current bleeding on major organ (brain, gastrointestinal)
Where this trial is running
Wŏnju, Kangwondo
- Yonsei Unviersity Wonju College of Medicin — Wŏnju, Kangwondo, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dialysis, Complications, Bleeding, dialysis, bleeding, nafamostat, heaprin