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IRCT20240228061124N1 IRCT 2024-10-18 Oroumia University of Medical Sciences Effect of Apixaban in catheter patency Studying the Efficacy of Apixaban in the prevention of tunneled cuffed catheter (TCC) thrombosis in operated hemodialysis patients 2024-03-10 anticipated 100 Complete https://irct.ir/trial/75730 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, two groups are to be randomized, with 50 participants receiving Apixaban and 50 participants not receiving it. Random Allocation Software Version 1.0 will be used for the random distribution, and block randomizing will be applied to guarantee equal distribution between the groups. Four participants will be the block size chosen by the Equal Size block option. Input into the program will be the overall sample size, the number of groups (Apixaban and non-Apixaban), and the block size. 3 Condition 1: End-stage renal disease. Condition 2: Thrombosis-related malfunction of tunneled-cuffed central venous catheters (TCC). Intervention 1: Intervention group: Patients will receive oral apixaban at a dose of 2.5 mg daily for 6 months. Intervention 2: Control group: Patients will receive routine treatment in Iran. Patients do not routinely receive anticoagulants to prevent catheter thrombosis. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Khodadad Ghaffari
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
Urmia Iran (Islamic Republic of) 5715664587 +98 44 3345 6686 khodadadg007@gmail.com Oroumia University of Medical Sciences scientific Khodadad Ghaffari
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
Urmia Iran (Islamic Republic of) 5715664587 +98 44 3345 6686 khodadadg007@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Hemodialysis patients undergoing TCC insertion in Imam Khomeini Hospital of Urmia. being older than 18 years 18 years no limit Both Patients who are treated with anticoagulant or other antiplatelet drugs. Patients who have a life expectancy of less than 3 months. Patients who have abnormal coagulation tests (PTT-PT-INR) before starting the intervention. Patients with known coagulation disorders. Patients with uncontrolled hypertension. Patients who have malignancy. Patients who are pregnant. Patients who are breastfeeding. Patients with an active infectious disease. Patients with liver failure. Patients who have a history of allergy to apixaban. Patients with a history of pulmonary embolism. N18.6 T82.49 End stage renal disease Other complication of vascular dialysis catheter Prevention Prevention Intervention group: Patients will receive oral apixaban at a dose of 2.5 mg daily for 6 months. Control group: Patients will receive routine treatment in Iran. Patients do not routinely receive anticoagulants to prevent catheter thrombosis. Thrombosis percentage of tunneled cuffed catheters. Timepoint: At the beginning of the study and then 6 and 12 months after the catheter was placed. Method of measurement: Observing the malfunction of the catheter in dialysis, bleeding and any related complications. Oroumia University of Medical Sciences Approved 2023-12-20 Research Ethics Committees of Urmia University of Medical Sciences - Imam Khomeini University Hospit Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)