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IRCT20190202042588N3 IRCT 2022-10-24 Shahid Beheshti University of Medical Sciences Evaluation of coagulation effects of tranexamic acid in patients undergoing surgery for cerebral supratentorial tumors Evaluation of coagulation effects of tranexamic acid on bleeding rate in patients undergoing surgery for cerebral supratentorial tumors 2022-06-22 anticipated 60 Complete https://irct.ir/trial/63044 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, random allocation (lottery method) will be used. For this purpose, the letter A (drug identifier) will be written on 30 sheets of paper, and all letters B will be written on the other 30 papers. It is closed and placed inside the box, then the papers will be randomly removed from the box for each patient without replacement, and the created sequence will be recorded, Blinding description: The different doses of the drug will be completely similar, and the nurse will not know about the drug dose, and the patient will not know about the drug dose or whether it is a placebo, and after testing, the patients' information will be delivered to the analyzer in two groups with numbers one and two. 2 supratentorial brain tumor. Intervention 1: Intervention group: In group A, after induction of general anesthesia and before incision of the skin, a dose of 20 mg / kg of transamic acid is injected after the initial loading dose. The dose of 1 mg / kg / h will also be injected as a maintenance dose throughout the surgery and in a continuous infusion. The maintenance dose will be injected until the skin is completely closed. Intervention 2: Intervention group: In group B, after induction of general anesthesia and before cutting the skin, a single dose of 20 mg / kg of tranxamic acid is injected and after the initial loading dose, 3 mg / kg / h of tranxamic acid will be injected until Complete skin closure perseveranceWill find. 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 There is no more information.
public Seyed Bashir Mirtajani
Masih Daneshvari Hospital, Tehran.
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 bashirmirtajani67@gmail.com Shahid Beheshti University of Medical Sciences scientific Sara Salarian
Imam Hossein Square, Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 sarasalarian@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All surgeries for supratentorial tumors Age over 16 years Discontinue drugs that cause coagulation disorders Women in non-pregnant status 16 years no limit Both history of coagulation disorders history of gastrointestinal disease history of liver disease history of heart disease history of renal failure (creatinine clearance less than 70min / mL, oliguria or dialysis 28 days before surgery) history of diabetes history of hypersensitivity disorders to ibuprofen, aspirin, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors history of asthma long-term use of anticonvulsant drugs smoking D33.0 Benign neoplasm of brain, supratentorial Treatment - Drugs Treatment - Drugs Intervention group: In group A, after induction of general anesthesia and before incision of the skin, a dose of 20 mg / kg of transamic acid is injected after the initial loading dose. The dose of 1 mg / kg / h will also be injected as a maintenance dose throughout the surgery and in a continuous infusion. The maintenance dose will be injected until the skin is completely closed. Intervention group: In group B, after induction of general anesthesia and before cutting the skin, a single dose of 20 mg / kg of tranxamic acid is injected and after the initial loading dose, 3 mg / kg / h of tranxamic acid will be injected until Complete skin closure perseveranceWill find. Hematocrit. Timepoint: Before surgery and one day after surgery. Method of measurement: Blood sampling. Bleeding volume. Timepoint: during surgery. Method of measurement: Direct and visual measurement. Shahid Beheshti University of Medical Sciences Approved 2022-03-08 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Arabi St., Yemen St.,Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)