The safety and effectiveness of anticoagulation strategies of Nafamostat Mesilate for hemodialysis in patients at high risk of blood clotting: a single-center randomized trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Nafamostat Mesilate:Flush the circuit with 1000ml of normal saline. Dissolve 20mg of Nafamostat Mesilate in at least 2 ml of 5% glucose and add it to 500ml of normal saline to pre‐fill the circuit and filter. Pre‐fill the circuit with 500ml of normal saline to remove any remaining Nafamostat Mesilate. Dissolve 100mg of Nafamostat Mesilate in 20ml of 5% glucose and simultaneously place it in a heparin pump at a starting speed of 4ml/h. The continuous injection dose of Nafamostat Mesilate is 20mg/h. The dosage is adjusted appropriately based on the patient's bleeding status, arterial and venous pressure, residual blood in the extracorporeal circuit, and coagulation test results, with a unit of 5mg/h.;Non‐anticoagulant group:Flush the circuit with 1000ml of normal saline prior to use. During dialysis, clamp the arterial end of the extracorporeal circuit every 60 minutes and flush the circuit and filter with 250ml of normal saline.; CONDITION: Maintenance hemodialysis patients PRIMARY OUTCOME: Extracorporeal circuit occlusion event; SECONDARY OUTCOME: Acute complication; INCLUSION CRITERIA: 1)Patients with end‐stage renal disease and receiving maintenance hemodialysis; 2)Aged 18 years or older; 3)Undergoing hemodialysis 2‐3 times per week, with each session lasting 4 hours; 4)Treatment modality is hemodialysis with a dialysate flow rate of up to 500ml/min and a blood flow rate of 3.5‐4ml/min.kg; 5)Presence of significant bleeding or high risk of bleeding (defined as within 3 days after active bleeding, within 3 days after invasive procedures or surgeries, or within 7 days before scheduled surgeries or invasive procedures); 6)Signed informed consent.
Epistemonikos ID: 4b3c88ae9e062dfc7576219edf59f982c8f7e0ca
First added on: Feb 20, 2024