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IRCT20200114046133N1 IRCT 2020-02-02 Kermanshah University of Medical Sciences Study of effect of tranexamic acid on the amount of bleeding and surgeons satisfaction in intertrochantric fracture Study of effect of tranexamic acid on the amount of bleeding during surgery and surgeons satisfaction in intertrochantric fracture 2020-01-21 anticipated 62 Complete https://irct.ir/trial/45089 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization performs by random number table which for every patients was assign a three digit code based on random table number. If right-sided digit is 2,3,5,6,9 labelled as group A and another digits labelled as group B, Blinding description: Patient are blinded to intervention. After spinal anesthesia, in intervention group, 1 gram tranexamic acid ( syringe B) and in control group ,5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. As for transparent state of drug,anesthesiologist and surgeon are not informed about injected drug or groups and just they are responsible over filling the questionnaire.in this research the person who collect the data as well as the statistical advisor are not aware of the allocation of group . 3 Inter trochantric fracture. Intervention 1: Intervention group:In intertrochanteric fracture which undergo internal fixation by plate, 1 gram tranexamic acid ( syringe B) and in control group ,5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. Intervention 2: Control group: In intertrochanteric fracture which undergo internal fixation by plate, 5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. As for transparent state of drug,anesthesiologist and surgeon are not informed about injected drug or groups and just they are responsible over filling the questionnaire. Yes - There is a plan to make this available What will be shared: effect of tranexamic acid on the amount of bleeding during surgery and surgeons satisfaction in intertrochantric fracture data set all collected deidentified IPD are to be shared . When: Starting 6 months after publication , the data will be available for 20 years . To whom: The data will be available only for people working in academic institutions . Conditions: No type of analyses on the document is allowed . Where to obtain: The preferred way of communication is via email. alireza_shafiei2010 @yahoo.com How to obtain: The requests will be discussed and the data would be available in three months . Comments:
public Alireza shafiei
taleghani hospital, shahid beheshti blvd, kermanshah town
Kermanshah Iran (Islamic Republic of) 6715847141 +98 87 3886 7021 alireza.shafiee@kums.ac.ir Kermanshah University of Medical Sciences scientific Alireza shafiei
taleghani hospital, shahid beheshti blvd, kermanshah city
kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3836 7989 alireza.shafiee@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients with intertrochantric fracture Patients with ASA ( American Society of Anesthesiologist ) 0 or 1 60 years 80 years Both Coagulation problems Anticoagulant drugs consumption Stroke Coronary Artery Diseases Hypertension Deep vein thrombosis Pulmonary Embolism Renal disease Seizure Treatment - Drugs Treatment - Drugs Intervention group:In intertrochanteric fracture which undergo internal fixation by plate, 1 gram tranexamic acid ( syringe B) and in control group ,5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. Control group: In intertrochanteric fracture which undergo internal fixation by plate, 5 milligram normal saline( syringe A) which dilute up to 100 milliliter with normal saline prepare by uninformed nurse and was handed to anesthesiologist that injected via intravenous during 10 minute. As for transparent state of drug,anesthesiologist and surgeon are not informed about injected drug or groups and just they are responsible over filling the questionnaire. Bleeding amounts. Timepoint: During surgery and 48 hours after surgery. Method of measurement: Blood amounts in suction; gauze's number; blood amounts in drain; hemoglobin after 48 hours. Surgeon satisfactions. Timepoint: During surgery. Method of measurement: Bozarret scale; Likert scale. Kermanshah University of Medical Sciences Approved 2020-01-18 Ethics committee of kermanshah University of Medical Sciences shahid beheshti blvd, kermanshah town kermanshah Kermanshah Iran (Islamic Republic of)