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IRCT20200429047236N1 IRCT 2020-05-12 Esfahan University of Medical Sciences Comparison of topical administration and infusion of tranexamic acid on the rate of bleeding in children with non-cyanotic heart disease after open heart surgery Comparison of topical and continuous infusion of Tranexamic Acid administration on bleeding in pediatric with non-cyanotic congenital heart disease 2019-10-12 anticipated 50 Complete https://irct.ir/trial/47550 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on the census and random allocation, the samples were divided into two groups of 25 people. This randomization was performed using Random Allocation software 2.0, in which patients were assigned to one of two groups based on the number of entries in the study. This is done by a nurse outside the research team and the groups are identified as A and B. The unit of randomization is individual. Also, randomization in two groups is Balanced Block Randomization, ie the number of people in two groups is equal, Blinding description: After obtaining informed consent from the patient's guardian (the study was performed on children), the study was one- blind side, in which only participants or patients were uninformed to the study groups, and the main staff and researchers and other colleagues who They were involved in this project, they were aware of the choice of group type, it was done. 2 Diseases of Atrial and Ventricular septum defect. Intervention 1: Intervention group:The first group of interventions includes patients undergoing continuous infusion of 50 mg per kg tranexamic acid from induction to sternum closure. Intervention 2: Intervention group:The second group of interventions are patients receiving topical administration of 50 mg per kg tranexamic acid, which has reached 20 ml with a normal saline solution. Before closing the sternum, it is poured into the pericardium and the patient's middle mediastan tubes are clamped for 20 minutes. (The nurse uses a sterile syringe to draw the drug into the syringe and then to a concentration of 20 ml). Yes - There is a plan to make this available What will be shared: Some of the data related to the result is available. When: 6 months after publishing the results To whom: All of the searchers Conditions: There are no special conditions Where to obtain: Executor or person in charge of the project How to obtain: Contact the executor or the person in charge of the project and up to one week after the contact (contact information is mentioned.) Comments:
public Minoo Montazeri
No.24 , Baharestan 9th, North Janat abad
Tehran Iran (Islamic Republic of) 1478777887 +98 21 4481 3915 minomah17@yahoo.com Esfahan University of Medical Sciences scientific Hamid Bigdelian
No. 308,Notrth Alley 1th, Alikhani Ave, Mehr Ave
Isfahan Iran (Islamic Republic of) 1478777887 +98 31 3260 3145 hamidbigdelian@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children under 14 kg and over 6 kg For the first time, they undergo cardiac surgery to correct the aforementioned non-cyanotic diseases with cardiac bypass. Clamp aortic time between 60 to 90 minutes CPB(cardio pulmonary bypass) time between 60 to 180 minute Hemoglobin(HB) above 8 mg per deciliter before surgery Minimum age 1 month and maximum age 9 years 1 month 9 years Both hemoglobin below 8 mg per deciliter before surgery Active non-revolutionary disease affecting postoperative recovery such as severe coagulation disorder, hemophilia and. I51.0 Cardiac septal defect, acquired Treatment - Drugs Treatment - Drugs Intervention group:The first group of interventions includes patients undergoing continuous infusion of 50 mg per kg tranexamic acid from induction to sternum closure. Intervention group:The second group of interventions are patients receiving topical administration of 50 mg per kg tranexamic acid, which has reached 20 ml with a normal saline solution. Before closing the sternum, it is poured into the pericardium and the patient's middle mediastan tubes are clamped for 20 minutes. (The nurse uses a sterile syringe to draw the drug into the syringe and then to a concentration of 20 ml). Bleeding rate in children with congenital non-cyanotic heart disease after open heart surgery. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: To determine the amount of bleeding, hemoglobin is measured based on arterial sampling and sent to a laboratory to measure and record arterial blood gases, and the unit is geram per deciliter. Time of intubation. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Hours and minute. Intensive care unit stay. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: Time and minute. Mount of derenage. Timepoint: Upon arrival at the intensive care unit, 6, 12, 24 and 48 hours after surgery. Method of measurement: According to cc. Esfahan University of Medical Sciences Approved 2019-10-09 ethics committe of Isfahan university of medical sciences No. 24, Baharestan 9th, Northen Janat Abad Tehran Tehran Iran (Islamic Republic of)