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IRCT20211208053326N1 IRCT 2022-01-30 Arak University of Medical Sciences The effect of intravenous Tranexamic acid on postoperative bleeding in patients with shaft femoral fractures The effect of intravenous Tranexamic acid on postoperative bleeding in patients with shaft femoral fractures 2022-01-20 anticipated 60 Complete https://irct.ir/trial/61116 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: The study is double-blind. The analysis is done by the analyzer and outcome evaluator and the participant. analyzer, evaluators, and participants are unaware of the consequences of grouping. The Resident is unaware of the drugs prescribed in each group and the orthopedic specialist prescribes the drug. Patients also do not know their group. 2-3 shaft femoral fractures. Intervention 1: Intervention group: Before the start of surgery, 10 milligram in kilogram of tranexamic acid (Tranexip in Iran -Caspian Company, 100 milligram in kilogram) will be given by slow intravenous injection with vital signs and standard monitoring careful control. Intervention 2: Control group: In the control group, they will receive the same amount intravenously before starting placebo surgery (normal saline). 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 Dr Mohsen Parsi Kameneh
Valiasr hospital, Valiasr squre
Arak Iran (Islamic Republic of) 3848176941 +98 86 3222 2003 parsi70@yahoo.com Arak University of Medical Sciences scientific Dr Mohsen Parsi Kameneh
Valiasr hospital, Valiasr squre
Arak Iran (Islamic Republic of) 3848176941 +98 86 3222 2003 parsi70@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients who are candidates for shaft and distal femoral fractures Lack of sensitivity to tranexamic acid No history of cerebral ischemia Lack of hematuria Surgery that lasts less than 3 hours no limit no limit Both hypertension history of cerebral ischemia anemia take any anticoagulants for 5 days before surgery platelets less than 150,000 before surgery history of myocardial ischemia underlying diseases such as kidney disease S72.3 Fracture of shaft of femur Treatment - Drugs Treatment - Drugs Intervention group: Before the start of surgery, 10 milligram in kilogram of tranexamic acid (Tranexip in Iran -Caspian Company, 100 milligram in kilogram) will be given by slow intravenous injection with vital signs and standard monitoring careful control. Control group: In the control group, they will receive the same amount intravenously before starting placebo surgery (normal saline). Bleeding amount. Timepoint: From 6 hours and 24 hours after surgery. Method of measurement: Millilitre. Hemoglobin amount. Timepoint: Before and after surgery. Method of measurement: Blood test. Hematocrit amount. Timepoint: Before and after surgery. Method of measurement: Blood test. Mortality. Timepoint: End of study. Method of measurement: Observation. Arak University of Medical Sciences Approved 2021-11-17 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)