Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2010
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedJune 23, 2015
June 1, 2015
4.9 years
June 11, 2015
June 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of filters used per hour
24 months
Secondary Outcomes (2)
Urea reduction ratio
24 months
Survival rate
24 months
Study Arms (2)
Nafamostat mesilate group
ACTIVE COMPARATORNafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy.
No anticoagulation group
PLACEBO COMPARATORNormal saline was used for maintenance anticoagulation during continuous renal replacement therapy.
Interventions
nafamostat mesilate use for anticoagulation
Eligibility Criteria
You may qualify if:
- Patients who were admitted to the intensive care unit and required CRRT
- active bleeding such as gastrointestinal bleeding and intracranial hemorrhage,
- activated partial thromboplastin time \> 60 s,
- prothrombin time-international normalized ratio \> 2.0,
- thrombocytopenia (\<100,000/µL), and
- surgery within 48 h before CRRT.
You may not qualify if:
- Pregnant or possibly pregnant women
- Patients who were allergic to nafamostat mesilate
- Patients who were hypercoagulable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
PMID: 33314078DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chan-Duck Kim, M.D., PhD
Associate Professor
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 23, 2015
Study Start
July 1, 2010
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 23, 2015
Record last verified: 2015-06