Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacem… (NCT07469072) | Clinical Trial Compass
RecruitingPhase 2
Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)
China92 participantsStarted 2026-04-07
Plain-language summary
This is a single-center, randomized, open-label, parallel-controlled clinical trial designed to investigate the anticoagulation efficacy and safety of different initial doses of Nafamostat Mesilate (NM) in ICU patients undergoing Continuous Renal Replacement Therapy (CRRT). Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital, Southern Medical University, to identify eligible participants based on inclusion and exclusion criteria. After obtaining informed consent, participants will be randomized into two groups.
On the basis of standardized CRRT treatment, the Low-Dose Group (Group A) will receive a continuous infusion of Nafamostat Mesilate at an initial dose of 20 mg/h, while the High-Dose Group (Group B) will receive an initial dose of 50 mg/h. The drug will be continuously infused pre-filter into the CRRT circuit. Dosage adjustments will be made for both groups to maintain target anticoagulation levels while ensuring that pre-filter safety limits are not exceeded. The primary outcome measure is filter lifespan, along with other secondary outcomes.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \& Gender: Aged 18 to 80 years, regardless of gender.
. Clinical Indication: Admitted to the Intensive Care Unit (ICU) with a confirmed indication for Continuous Renal Replacement Therapy (CRRT) and an expected treatment duration of greater than 24 hours.
. Coagulation Status: Normal coagulation function prior to CRRT initiation, defined as:International Normalized Ratio (INR) ≤ 1.5,Fibrinogen (FIB) ≥ 1.5 g/L,Activated Partial Thromboplastin Time (APTT) ≤ 45 seconds
. Body Mass Index (BMI): 18.5 kg/m² ≤ BMI ≤ 25 kg/m².
. Informed Consent: Written informed consent obtained from the patient or their legally authorized representative.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Filter Lifespan
Timeframe: From the initiation of Nafamostat Mesilate anticoagulation until filterreplacement or discontinuation of CRRT (up to 72 hours per filter session).
. Hypersensitivity: Known allergy or hypersensitivity to Nafamostat Mesilate or any component of the formulation.
. Active Bleeding: Presence of active bleeding or a high risk of bleeding that contraindicates anticoagulation (e.g., active gastrointestinal bleeding, intracranial hemorrhage, or recent major surgery with a high bleeding risk).
. Pregnancy/Lactation: Pregnant or breastfeeding women.
. Concurrent Anticoagulation: Current use of other systemic anticoagulants (e.g., unfractionated heparin, low molecular weight heparin, warfarin, or direct oral anticoagulants) that cannot be discontinued.
. Concurrent Extracorporeal Support: Concurrent use of other extracorporeal life support or blood purification therapies that may interfere with coagulation assessment, such as Extracorporeal Membrane Oxygenation (ECMO), Intra-Aortic Balloon Pump (IABP), or Plasma Exchange (PE).
. Severe Liver Dysfunction: Severe hepatic impairment (Child-Pugh Class C) or baseline total bilirubin levels exceeding 5 times the upper limit of normal.
. Limited Life Expectancy: Expected survival time of less than 24 hours due to the progression of underlying disease.
. Conflicting Trials: Current participation in another interventional clinical trial that may influence the outcomes of this study.