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IRCT20230607058400N1 IRCT 2023-06-13 Gorgan University of Medical Sciences The effect of vitamin C administration on the Consumption of blood products in patients undergoing open heart surgery in two groups of tranexamine and vitC+tranexamine (randomized clinical trial) The effect of vitamin C administration on the Consumption of blood products in patients undergoing open heart surgery in two groups of tranexamine and vitC+tranexamine (randomized clinical trial) 2023-06-22 anticipated 120 Complete https://irct.ir/trial/70531 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: There is no unique specification, Randomization description: Randomization is done through random blocks of four, the unit of randomization will be individual (each patient), random assignment of patients to groups is done in the order of permutations of generated random blocks. For this study, For this study, 15 blocks of 4 will be produced using the software, so that in each block, two members from group one and two members from group two are considered, Blinding description: Patients do not know their treatment group, and the medical personnel and the patient evaluator will not know the type of drug, and only the specialist responsible for the injection based on the code inserted on the serum will know about its conten sot In this study, the outcome assessor and the data analyst also do not know the type of study. N/A Haemorrhagic condition in open heart surgery. Intervention 1: Intervention group: transamine injection alone 50Mg/kg bolus before surgical incision (Iran. Co Pharmaceutical Tamin Caspian®, Tranexip ) Half an hour before the surgery, the patient will be infused with 2 grams of vitamin C ampoule along with 100 cc of normal saline serum (Daroupakhsh Factory-Iran-Tehran) and then 1000 mg of vitamin C will be given every day for the first 4 days. Intervention 2: Control group: transamine injection alone 50Mg/kg bolus before surgical incision (Iran. Co Pharmaceutical Tamin Caspian®, Tranexip ). 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 further information
public Fozieh Bakhsha
Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd
Gorgan Iran (Islamic Republic of) 7451549341 +98 17 3245 0663 bakhsha_fo@yahoo.com Gorgan University of Medical Sciences scientific Fozieh Bakhsha
Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd
Gorgan Iran (Islamic Republic of) 7451549341 +98 17 3245 0663 bakhsha_fo@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Age between 30-80 years EF>30% BMI<26 written informed consent no history of drug sensitivity first heart surgery no history of disorders and coagulation factors hemoglobin more than 10 gr/dl 30 years 80 years Both Dissatisfaction and willingness to participate in the study D69.9 Hemorrhagic condition, unspecified Treatment - Drugs Treatment - Drugs Intervention group: transamine injection alone 50Mg/kg bolus before surgical incision (Iran. Co Pharmaceutical Tamin Caspian®, Tranexip ) Half an hour before the surgery, the patient will be infused with 2 grams of vitamin C ampoule along with 100 cc of normal saline serum (Daroupakhsh Factory-Iran-Tehran) and then 1000 mg of vitamin C will be given every day for the first 4 days. Control group: transamine injection alone 50Mg/kg bolus before surgical incision (Iran. Co Pharmaceutical Tamin Caspian®, Tranexip ) Measurement of blood loss during and after surgery. Timepoint: at Hour 0, 2, 4, 6, 8, 10, 12. Method of measurement: visual estimation of blood loss in bottles. Measuring length of stay in ICU. Timepoint: Days of hospitalization in the ICU. Method of measurement: number of days. Measuring length of stay in hospital. Timepoint: Days of hospitalization in hospital. Method of measurement: number of days. Measuring the amount of hemoglobin drop. Timepoint: after surgery. Method of measurement: blood test. Gorgan University of Medical Sciences Approved 2023-04-25 Ethics committee of Golestan University of Medical Sciences International Medical Faculty, Golestan University of Medical Sciences, at the beginning of Shat Kola road, Hirkan blvd Gorgan Golestan Iran (Islamic Republic of)