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IRCT20210703051769N1 IRCT 2021-08-22 Esfahan University of Medical Sciences Assessment of effect of Tranexamic acid on hemorrhage reduction in hysterectomy Assessment of effect of intravenus tranexamic acid on hemorrhage reduction during and after hysteretomy in comparison with control group 2016-08-22 anticipated 60 Complete https://irct.ir/trial/57272 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With Random allocation software patients got numbers from 1 to 60.If the paitient had even numder it has entered to T group and if the patient had odd numder it has entered to S group.Group T recieved 1 gr tranexamic acid,in the other hand group S recieved the same amount of normal saline, Blinding description: In this study, clinical caregiver and patients participating in the study were blind. All patients were aware of the benefits and the adverse effects of clinical trial, but they were unaware about who received the intervention. Clinical caregiver, surgeon and anesthesiologist were blind. Tranexamic acid was administered 20 minutes before the surgery by an anesthesiologist.Some of them received placebo (normal saline solution). 3 Condition 1: Hysterectomy. Condition 2: Blood transfusion. Condition 3: Tranexamic acid. Intervention 1: Intervention group: recieve 1 gr tranexamic acid as slow intravenus bolus.Tranexamic injection was prepared by diluting 1 gr (10ml) tranexamic acid with 20 ml of5% glucose. Intervention 2: Control group: recieve equal volume of normal saline (10ml). Yes - There is a plan to make this available What will be shared: All data can be shared after unidentifiable individuals. When: 6 month after publication,data will be accessible. To whom: The study will be available for researchers who work in academic and scientific institutions. Conditions: Due to the unrecognizable people,no restriction will apply. Where to obtain: Ensiyeh bahadoran ; Phone number:0098 9127689597 ;Email:bahadoran.ensiyeh@yahoo.com How to obtain: Data will be provided in 1-2 weeks. Comments:
public Ensiyeh Bahadoran
No 21, Bahman Alley, Padegan Street
Qazvin Iran (Islamic Republic of) 3415697171 +98 28 3333 0923 Bahadoran.ensiyeh@yahoo.com Qazvin University of Medical Sciences scientific Azadeh Bahadori
Hajar Hospital, Parastar Street
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 Azadeh.bahadori93@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Candidate of vaginal or abdominal hystrectomy Between 35-70 years old American society of anesthesiologist (ASA) grade for physical status 1 or 2 35 years 70 years Female Anemia Hepatic dysfunction Renal dysfunction Serious cardiac disease Serious respiratory disease Acquired or congenital coagulopathy Previous history of deep venus thrombosis or thromboembolic disease ASA more than 2 Sensitive to tranexamicacid Z90.710 Acquired absence of both cervix and uterus Treatment - Drugs Placebo Intervention group: recieve 1 gr tranexamic acid as slow intravenus bolus.Tranexamic injection was prepared by diluting 1 gr (10ml) tranexamic acid with 20 ml of5% glucose. Control group: recieve equal volume of normal saline (10ml). Blood loss. Timepoint: During and after sugery. Method of measurement: During the surgery by weighting swabs,spinges,operative drapes and measuring the volume in suction buttles after surgery by measuring the drain collectors in post anesthesia care unit. Blood transfusion. Timepoint: During and 12 hours after surgery. Method of measurement: Pack cell. Hemoglobin. Timepoint: During and 12 hours after surgery. Method of measurement: Blood test. Hematocrit. Timepoint: Before and 12 hours after surgery. Method of measurement: Blood test. Operation time. Timepoint: Operation time. Method of measurement: Timer. Esfahan University of Medical Sciences Approved 2017-07-02 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)