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Study aim
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Evaluation effect of intravenous Tranexamic acid on postoperative bleeding in patients with shaft femoral fractures
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Design
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The study will be double blind and clinical trial.60 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
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Settings and conduct
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Patients candidate for surgery of shaft femoral fractures in valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: All patients who are candidates for shaft and distal femoral fractures, lack of sensitivity to tranexamic acid, surgery that lasts less than 3 hours
Exclusion criteria: underlying diseases such as kidney disease, history of myocardial ischemia, hypertension, history of cerebral ischemia, history of thromboembolism, anemia, take any anticoagulants for 5 days before surgery, hematuria, platelets less than 150,000 before surgery
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Intervention groups
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In the 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.
In the control group, they will receive the same amount intravenously before starting placebo surgery (normal saline).
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Main outcome variables
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Bleeding amount, hemoglobin amount, hematocrit amount, mortality