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IRCT20200516047461N1 IRCT 2020-05-20 Esfahan University of Medical Sciences The effects of Warfarin on permacath function Evaluating the effects of Warfarin on permacath function in hemodialysis patients 2020-01-05 anticipated 86 Complete https://irct.ir/trial/48193 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The study population divided into two groups (intervention and control ) by using Random Allocation software. 2-3 Chronic kidney disease. Intervention 1: Intervention group: According to the inclusion and exclusion criteria 86 patients (43 in the intervention group and 43 patients in the control group) recruited. The patients are a candidate for second-time permcath placement. All of the studied patients undergo standard surgical procedure for the permanent hemodialysis catheter embedding a skilled target surgeon performs all of the procedures and all of the embedded catheters are from the Arrow Company made in Ireland. In the next step, treatment with warfarin initiate for the participants in the intervention group (Warfager tablet, Hoger Danesh Daroo company made in Iran) as soon as the cessation of the surgical procedure and its dose will be adjusted in order to set INR in the range of 1.5-2. Furthermore, INR will be checked monthly in order to adjust the warfarin dose if needed, and prevent from any probable warfarin-induced hemorrhagic event. The participants were discharged on the next day of catheter embedding and were re-visit monthly until a year following the surgery to a requirement for the excision of the catheter. Besides, in order to initiate warfarin therapy, the baseline INR was recorded from the laboratory tests of the patients taken before the surgical procedure of permanent catheter embedding. Intervention 2: Control group: 43 Patients in the control group undergo a standard surgical procedure for the permanent hemodialysis catheter embedding. A skilled target surgeon performs all of the procedures, and all of the embedded catheters are from the Arrow Company made in Ireland. The control group did not receive any anticoagulants and discharged after the surgery. The participants will be re-visited monthly until a year following the surgery to a requirement for the excision of the catheter. Yes - There is a plan to make this available What will be shared: After making the patients' personal information unrecognizable, the data can be published and shared. When: Three months after publishing the results, the data will be accessible. To whom: Medical researchers Conditions: The documented data is going to be presented to the Vice-Chancellery for Research and Technology of Isfahan University of medical sciences and the publisher journal. Where to obtain: The Vice-Chancellery for Research and Technology of isfahan university of medical sciences How to obtain: Referring to the Vice-Chancellery for Research and Technology of Isfahan University of medical sciences and having a confirmation from the chief executor of the research the documentation can be accessible. Comments:
public Milad Golshani nasab
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 5555 milad.golshani@gmail.com Esfahan University of Medical Sciences scientific Milad Golshani nasab
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 5555 milad.golshani@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who were a candidate for the second time embedding of permanent arteriovenous catheters Informed consent to participate in the study Age above 18 years old 18 years no limit Both History of major hemorrhages (requiring blood transfusion, retroperitoneal or intracranial hemorrhage, inducing hypovolemia, leading to more than two units decrease in hemoglobin) within the previous three months Progressive diabetic retinopathy Less than 12 months of life-expectancy because of systemic disease or malignancies Poorly controlled hypertension (systolic blood pressure>200 mmHg or diastolic blood pressure>100 mmHg measured three times within two weeks) Absolute platelet count less than 100000 International normalized ratio (INR)≥1.3 Partial thrombin time (PTT)≥ 5 folds than the normal range Hypersensitivity to Warfarin Active peptic ulcer Pregnancy or lactation Documented aortic aneurysm N18 Chronic kidney disease (CKD) Prevention Prevention Intervention group: According to the inclusion and exclusion criteria 86 patients (43 in the intervention group and 43 patients in the control group) recruited. The patients are a candidate for second-time permcath placement. All of the studied patients undergo standard surgical procedure for the permanent hemodialysis catheter embedding a skilled target surgeon performs all of the procedures and all of the embedded catheters are from the Arrow Company made in Ireland. In the next step, treatment with warfarin initiate for the participants in the intervention group (Warfager tablet, Hoger Danesh Daroo company made in Iran) as soon as the cessation of the surgical procedure and its dose will be adjusted in order to set INR in the range of 1.5-2. Furthermore, INR will be checked monthly in order to adjust the warfarin dose if needed, and prevent from any probable warfarin-induced hemorrhagic event. The participants were discharged on the next day of catheter embedding and were re-visit monthly until a year following the surgery to a requirement for the excision of the catheter. Besides, in order to initiate warfarin therapy, the baseline INR was recorded from the laboratory tests of the patients taken before the surgical procedure of permanent catheter embedding. Control group: 43 Patients in the control group undergo a standard surgical procedure for the permanent hemodialysis catheter embedding. A skilled target surgeon performs all of the procedures, and all of the embedded catheters are from the Arrow Company made in Ireland. The control group did not receive any anticoagulants and discharged after the surgery. The participants will be re-visited monthly until a year following the surgery to a requirement for the excision of the catheter. Permcath function. Timepoint: In every hemodialysis session. Method of measurement: Catheter clotting defined as the gross visible occlusion of the catheter or the dialysis performance with less than 250 ml per minute velocity. Vice-Chancellery for Research and Technology Approved 2019-04-20 Ethics committee of Isfahan university of medical sciences Hezar Jerib Street,Isfahan university of medical sciences Isfahan Isfehan Iran (Islamic Republic of)