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IRCT20190525043701N1 IRCT 2019-08-02 Ahvaz University of Medical Sciences Oral Tranexamic Acid in Spinal Surgery The effect of oral Tranexamic Acid for bleeding in Spinal Surgery 2640-10-02 anticipated 129 Pending https://irct.ir/trial/40532 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized on the basis of random numbers table in two groups of recipients TXA (n = 64) and placebo recipients (n = 65). All surgical procedures in this study were performed by a surgical team and the technique used was similar. The randomization in this study will be done as TXA group (25 mg/kg) received four tablets of 500 mg and the placebo group also received a full dose of 2 mg of small pills that appeared to be the same but dose not contain any active substance, Blinding description: the subjects (patients) and researcher (Neurosurgery resident) are not aware of the type of medication. After collecting the data and the results of their analysis by the implementer, the type of each drug is identified and all surgeries are performed to control the confounding factors by a surgeon, and there is only one anesthesiologist for all patients. N/A The effect of oral Tranexamic Acid for bleeding in Spinal Surgery. Intervention 1: Intervention group: Patients aged 18 to 60 years who are candidates for spinal surgery for any cause other than trauma, will be used on the day before surgery and 500 mg on the morning of surgery of the Trancehexamic acid (TXA) . Intervention 2: Control group: Patients between the ages of 18 and 60 who are candidates for spinal surgery for any reason other than trauma will be used placebo pills on the day before surgery and 500 mg in the morning of surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Nour Mohammad Mamizadeh
Golestan Blvd., Farvardin Street
Ahvaz Iran (Islamic Republic of) 33118-61357 +98 61 3374 3032 mhmdmamizadeh@gmail.com Ahvaz University of Medical Sciences scientific Nour Mohammad Mamizadeh
Golestan Blvd., Farvardin Street
Ahvaz Iran (Islamic Republic of) 33118-61357 +98 61 3374 3032 mhmdmamizadeh@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) being in a range of ages 18 to 60 lack of cardiovascular disease Patients undergoing lumbar and back spine surgery, including discopathies with spinal fusion, and discopathies more than two levels or two-sided spinal cord. 18 years 60 years Both unwillingness to participate in the study abnormal bleeding platelet count less than 150,000 (k) a history of thrombosis or embolism severe allergies using drugs that interact with hemostasis in the blood high and uncontrolled blood pressure (blood pressure mre than 160/90) obese people (body mass index more than 30). D69.9 Hemorrhagic condition, unspecified Treatment - Drugs Placebo Intervention group: Patients aged 18 to 60 years who are candidates for spinal surgery for any cause other than trauma, will be used on the day before surgery and 500 mg on the morning of surgery of the Trancehexamic acid (TXA) . Control group: Patients between the ages of 18 and 60 who are candidates for spinal surgery for any reason other than trauma will be used placebo pills on the day before surgery and 500 mg in the morning of surgery. The amount of Bleeding after Oral Administration of Tranexamic acid. Timepoint: Before and after intervention will measure. Method of measurement: The amount of blood collected in cc. The coagulation tests. Timepoint: Will be checked during and 72 hours after the operation. Method of measurement: According to standard one-stage APTT method. Ahvaz University of Medical Sciences Approved 2018-02-14 Ahvaz Jundishapur University of Medical Sciences’ Ethics Committee Golestan Blvd., Farvardin Street Ahvaz Khouzestan Iran (Islamic Republic of)