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IRCT20120527009878N6 IRCT 2019-04-04 Deputy of Research of Tabriz University Assessment the efficacy of Tranexamic Acid in reducing blood loss after laminectomy and postrolateral fusion of spine Assessment the efficacy of Tranexamic Acid in reducing blood loss after laminectomy and postrolateral fusion of spine 2019-03-18 anticipated 50 Complete https://irct.ir/trial/37109 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selected patients will be divided into two groups of TXA receptors (n = 25) and placebo recipients (n = 25) according to the random numbers table. All surgical procedures in this study were performed by a surgical team and the technique used was similar. The randomization in this study is that TXA (15 mg / kg) in single dose and placebo (normal saline 0.09%), which are pre-prepared with the names 1 and 2 in separate syringes, are exactly Prior to cutting by anesthetist technician, an uncontrolled intravenous anesthesia is administered to the patient and the patient is injected randomly, and then an operation is performed on the patient, Blinding description: The selected patients who enter the operating room will be divided into two groups of TXA receptors (n = 25) and placebo recipients (n = 25) according to the random numbers table, which will be informed by the nurse of the operating room. And they will not be aware of it during the operation of the surgical team. All surgical procedures in this study were performed by a surgical team and the technique used was similar. The statistical analyzer is also unaware of the drug method. The basis of the study will be three blinds. After analysis, the head nurse will be asked the type 1 and 2 methods. N/A Topical administration of TXA helps control bleeding and prevents unwanted side effects. Intervention 1: Intervention group: Patients between the ages of 20 and 60 who are candidates for laminectomy 2 or more space and fissure with a pedicle screw (CD insertion) for any cause other than trauma at the end of the surgery and before the final fixation and drainage of the trance Topical hexamic acid will be used. Intervention 2: Control group: Patients aged between 20 and 60 years who are candidates for laminectomy of 2 or more spaces and fistula with a pedicle screw (CD insertion) for any cause other than trauma at the end of the surgery and before the final fixation and embedding Dren will use the drug. 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 No more information
public Moslem Shakeri
Golgasht ave
Tabriz Iran (Islamic Republic of) 5166614756 +98 44 1333 8507 shakeri@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mansour Valaie
Golgasht ave
Tabriz Iran (Islamic Republic of) 5166614756 +98 44 1333 8507 mvalaie@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with candidate laminectomy and fissure-medial fistula, who refer to Imam Reza Hospital in Tabriz all patients aged 20 to 60 years 20 years 60 years Both Use of anticoagulant drugs such as ASA and depiridamole high PT, PTT, INR for any cause history of any thrombotic event such as CVA and MI history of bleeding disorders history of TBI history of CPR kidney failure OCP use, pregnancy Or lactation. Also, patients who need blood transfusion before or during surgery for any reason M48.06 Spinal stenosis, lumbar region Treatment - Drugs Placebo Intervention group: Patients between the ages of 20 and 60 who are candidates for laminectomy 2 or more space and fissure with a pedicle screw (CD insertion) for any cause other than trauma at the end of the surgery and before the final fixation and drainage of the trance Topical hexamic acid will be used. Control group: Patients aged between 20 and 60 years who are candidates for laminectomy of 2 or more spaces and fistula with a pedicle screw (CD insertion) for any cause other than trauma at the end of the surgery and before the final fixation and embedding Dren will use the drug. Determination of the Effect of Tranexamic Acid on the Transfusion Level of Blood Transfusion in Patients under Laminectomy and Fibrous Fistula. Timepoint: During surgery and duration of hospitalization after surgery. Method of measurement: Blood volume injected to the patient in milliliters. Determination of the Effect of Tranexamic Acid on the Length of Hospitalization During Laminectomy and Fistula. Timepoint: During surgery and duration of hospitalization after surgery. Method of measurement: Duration of hospitalization in hospital days. Determine the effect of tranexamic acid on the amount of blood collected in hemovac in patients undergoing laminectomy and fissure of the posterolateral of the spine. Timepoint: duration of hospitalization after surgery. Method of measurement: The amount of blood accumulated in CC. Deputy of Research of Tabriz University Approved 2019-03-12 Ethics Committee of Tabriz Medical science Azadi Ave , Golghast St , Imam Reza Hospital Tabriz East Azarbaijan Iran (Islamic Republic of)