]>
IRCT20220516054868N2 IRCT 2023-11-30 Esfahan University of Medical Sciences Evaluation the possible side effects of rivaroxaban in patients with pulmonary valve replacement or Fontan surgery. Evaluation and comparing the possible side effects of rivaroxaban with warfarin in patients with pulmonary valve replacement or Fontan surgery. 2023-12-22 anticipated 75 Complete https://irct.ir/trial/73902 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The identification of patients in terms of age and gender will be done in the PVR group. In this study, randomization will be done by blocked randomization method, using the software, 8 blocks of 8 for the sample size of 60 (30 people in each group) will be calculated for 2 study groups. Each person will be identified with a unique code (consisting of two letters and a Latin number). After obtaining informed consent from the patient and parents, to allocate the patient to each of the 2 groups of the study, an envelope containing a unique code and treatment group will be delivered to the patient or his parents. Before starting the treatment, the associate nurse of the plan will open the envelope and specify the type of intervention. 4 Patients who have undergone pulmonary valve replacement and Fontan surgery.. Intervention 1: Intervention group in patients with a history of pulmonary valve replacement surgery: use of rivaroxaban drug for three to six months after surgery with a dose of: weight over fifty kilos ten milligrams daily, weight thirty to fifty kilos daily seven and a half milligrams daily, Twenty to thirty kilos, two and a half milligrams every twelve hours, ten to twenty kilos, one and seven tenths milligrams every twelve hours, and the manufacturer of Apixaban. Thirty patients. Intervention 2: Control group in patients with a history of pulmonary valve replacement surgery: Use of warfarin tablets for 3-6 months with a warfarin dose of one tenth to three tenths of a milligram per kilogram of the patient's weight and with INR control for three to six months after The surgery continues. Thirty patients. Intervention 3: Intervention group: There are 15 patients who have undergone Fontan surgery and have been receiving warfarin for the prevention of thromboembolic complications for at least 6 months. In these patients, warfarin will be stopped, and according to existing protocols, when the INR reaches one half, rivaroxaban will be started instead, and if tolerated, it will continue for one year, and side effects will be compared before and after starting rivaroxaban. The dose of warfarin and rivaroxaban is the same for pulmonary valve replacement patients. Yes - There is a plan to make this available What will be shared: Patients who had complications while taking drugs. When: Unclear To whom: researchers Conditions: Use in other studies Where to obtain: executor of plan How to obtain: Apply by email Comments:
public Mohadeseh Ghasemi
Keshavarz blvd, Sohrevardi intrsec, Janbazan st, Molana st, Erfan st, Subsection 8th, No: 257, level 2th
Isfahan Iran (Islamic Republic of) 8174796149 +98 31 3778 5759 ghasemi.mhds@gmail.com Esfahan University of Medical Sciences scientific Bahar Dehghan
Third Moshtaq st
Isfahan Iran (Islamic Republic of) 8158388997 ۹۸-۳۱-۳۲۶۰۰۹۶۱۵ dr.bahardehghan@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Obtaining informed consent (patient or parents) Age 5-18 years old Performed pulmonary valve replacement or Fontan surgery 5 years 18 years Both Intolerance or sensitivity to warfarin Intolerance or sensitivity to rivaroxaban q20.8 Other congenital malformations of cardiac chambers and connections Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group in patients with a history of pulmonary valve replacement surgery: use of rivaroxaban drug for three to six months after surgery with a dose of: weight over fifty kilos ten milligrams daily, weight thirty to fifty kilos daily seven and a half milligrams daily, Twenty to thirty kilos, two and a half milligrams every twelve hours, ten to twenty kilos, one and seven tenths milligrams every twelve hours, and the manufacturer of Apixaban. Thirty patients Control group in patients with a history of pulmonary valve replacement surgery: Use of warfarin tablets for 3-6 months with a warfarin dose of one tenth to three tenths of a milligram per kilogram of the patient's weight and with INR control for three to six months after The surgery continues. Thirty patients Intervention group: There are 15 patients who have undergone Fontan surgery and have been receiving warfarin for the prevention of thromboembolic complications for at least 6 months. In these patients, warfarin will be stopped, and according to existing protocols, when the INR reaches one half, rivaroxaban will be started instead, and if tolerated, it will continue for one year, and side effects will be compared before and after starting rivaroxaban. The dose of warfarin and rivaroxaban is the same for pulmonary valve replacement patients. Major and minor bleeding. Timepoint: 3-6 months. one year. Method of measurement: questionnaire-The tool does not have a specific measurement and is descriptive. Stroke. Timepoint: 3-6 months. one year. Method of measurement: questionnaire-The tool does not have a specific measurement and is descriptive. Thromboembolic events. Timepoint: 3-6 months. one year. Method of measurement: questionnaire-The tool does not have a specific measurement and is descriptive. Esfahan University of Medical Sciences Approved 2023-10-29 Ethics committee of Isfahan University of Medical Sciences- Medical School Hezarjerib st, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)