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IRCT20200203046351N1 IRCT 2020-12-16 Bagheiat-allah University of Medical Sciences topical tranexamic acid in perioperative blood loss of the posterior lumbar spinal surgery Role of topical tranexamic acid in reducing perioperative blood loss in traumatic and non-traumatic patients undergoing posterior lumbar spinal surgery 2020-12-04 anticipated 104 Complete https://irct.ir/trial/52583 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: By usage of Randlist software, each participant will be assigned a random number. Even numbers will enter in the intervention group and odd numbers will be the placebo group. Another person who is unaware of the randomization and has not take part in the intervention, prepares the solution for washing during the operation based on the even or odd code of the patients. The randomization method is simple and the unit is individual randomization, Blinding description: Patients, surgeon and the anesthesia team are blinded to intervention. Based on the codes, The same operating room technician will use medication in the case group and in the control group only normal saline is used. 3 Condition 1: هرنی دیسک کمر. Condition 2: شکستگی مهره های کمری ستون فقرات. Intervention 1: Intervention group: solution of 3 gr TXA in 100 cc normal saline will use for intermittent washing and soaking sterile gases for packing. Intervention 2: Control group: Normal saline. Yes - There is a plan to make this available What will be shared: all of the data can be shared. When: 6 months after publication To whom: Researchers of university centers Conditions: Maintain data security Permission of the financing organization and the research center Where to obtain: E-mail How to obtain: After submitting the request, coordination will be done with the research center of the study and the data collection canter and will be sent after approval. The process will take about 2 months. Comments:
public Eslamian, Mohammad
No. 19, Jamalzadeh st
Tehran Iran (Islamic Republic of) 1418835568 +98 21 6659 6934 md.eslamian@gmail.com Tehran University of Medical Sciences scientific Mohammad Eslamian
Unit 10, 3rd Floor, No. 19, Etemad Alley, North Jamalzade Ave
Tehran Iran (Islamic Republic of) 1418835568 +98 21 6659 6934 md.eslamian@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with age between 18 to 75 years . Patients whom needs posterior lumbar spinal surgery Traumatic patients ( in the first 3 weeks after injury) Non-traumatic patients (with maximum 4 spinal level envolved) 18 years 75 years Both History of thromboembolism Emergent surgery with indications other than neurosurgical indications Treatment with other drugs that affect blood coagulation such as sodium valproate Any transexamic acid intake before (eg polymenorrhea in women or in dentistry) Treatment with anticoagulants Treatment with antiplatelets Spinal penetrating injury Hemodynamical unstability History of epilepsy or seizure Liver malfunction Renal failure Abnormal results of laboratory coagulation tests Patient's reluctance M51.26 S32.009A Other intervertebral disc displacement, lumbar region Unspecified fracture of unspecified lumbar vertebra, initial encounter for closed fracture Treatment - Drugs Placebo Intervention group: solution of 3 gr TXA in 100 cc normal saline will use for intermittent washing and soaking sterile gases for packing. Control group: Normal saline Intraoperative blood loss. Timepoint: At the end of the operation. Method of measurement: with use of standard anesthesia chart by ml. Duration of hospitalization. Timepoint: Time of discharge. Method of measurement: Questionnaire. Coagulation studies. Timepoint: At the beginning of the study and post op. Method of measurement: questionnaire. Duration of returning to work. Timepoint: 2 month post op. Method of measurement: questionnaire. Bagheiat-allah University of Medical Sciences Approved 2019-12-21 Ethics Committee of Baqiyatallah Hospital No 37, Dr Sahriati Ave Hamedan Hamadan Iran (Islamic Republic of)