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IRCT20211026052874N1 IRCT 2025-01-11 Mashhad University of Medical Sciences Study of the Rivaroxaban 10mg on Tunneled cuffed catheter patency Study of the Rivaroxaban 10mg on Tunneled cuffed catheter patency in hemodialysis patients 2024-08-10 anticipated 50 Complete https://irct.ir/trial/69896 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research, Other design features: The patients are divided into two researcg groups and control groups, Randomization description: Participants will be assigned to two intervention and control groups in order of arrival and based on a randomization sequence that will be generated in advance, which is an unpredictable sequence and its arrangement is completely random. A block randomization method with blocks of 8 will be used to allocate samples. Thus, using the site www.sealedenvelope.com, blocks of 8 letters A and B will be randomly generated based on the sample size. The order of the letters A and B in each block from the first block to the last block is considered as the randomization sequence. The generation of these blocks and their random sequence is entirely done by this site, and the researcher is not aware of their sequence, Blinding description: The analyst will be unaware of the intervention and control groups. 3 Dysfunctional cuffed tunneled dialysis catheter. Intervention 1: Intervention group: Dialysis patients with a tunneled cuffed catheter are given one 10 mg rivaroxaban tablet daily. Patients are followed up at one, three, and six month intervals, and the number of catheter dysfunctions due to thrombosis is recorded. Intervention 2: Control group: After insertion of a cuffed dialysis catheter according to the current routine treatment process, no medication is given to the patient. Patients are followed up at one, three, and six month intervals and the number of cases of catheter dysfunction due to thrombosis is recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no additional data
public Dr. Jamal Jalili Shahri
Shahid Kaveh Blvd., Velayat Hospital
Mashhad Iran (Islamic Republic of) 9177890001 +98 51 3842 9500 Jalilisj@mums.ac.ir Mashhad University of Medical Sciences scientific Jamal Jalili Shahri
ُShahid Kaveh Blvd., Velayat Hospital
Mashhad Iran (Islamic Republic of) 9177890001 +98 51 3872 2137 Jalilisj@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) ESRD patients who are candidates for Tunneled hemodialysis catheter placement as a permanent hemodialysis access no limit no limit Both Presence of a coagulation disorder Two weight ranges (less than 50 kg and more than 150 kg) Receiving anticoagulant medication for another reason, such as cardiac DVT, atrial fibrillation, or an artificial heart valve Untreated malignant lesion of the central nervous system (CNS) Active lesion or active malignancy in the GI and GV system Platelet count less than 70,000 Treatment - Drugs Treatment - Drugs Intervention group: Dialysis patients with a tunneled cuffed catheter are given one 10 mg rivaroxaban tablet daily. Patients are followed up at one, three, and six month intervals, and the number of catheter dysfunctions due to thrombosis is recorded. Control group: After insertion of a cuffed dialysis catheter according to the current routine treatment process, no medication is given to the patient. Patients are followed up at one, three, and six month intervals and the number of cases of catheter dysfunction due to thrombosis is recorded. Thrombosis of cuffed catheter with tunneled dialysis. Timepoint: one month and three months and six months. Method of measurement: Catheter patency rates in the first, third, and sixth months after catheter insertion and cases of catheter dysfunction due to intraluminal thrombosis in both intervention and control groups. Mashhad University of Medical Sciences Approved 2020-09-22 Ethics Committee of Mashhad University of Medical Sciences 4th Floor,Vascular Surgery Office , Velayat Hospital , Shahid Kaveh Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)