Clinical Study On The Effect And Safety Of Tranexamic Acid In Closed Reduction Of Femoral Shaft Fracture

Objective:The objective of this trial was to assess the efficacy and safety of intravenous（IV）administration of TXA before operation in patients treated with intramedullary fixation of femoral shaft fracture.DVT was counted during hospitalization.The study aims to provide theoretical basis for clinical application of tranexamic acid in the surgery of femoral shaft fracture.Methods:From September 2017 to December 2019,patients undergoing closed reduction of femoral shaft fracture at Third Hospital of Hebei Medical University were eligible for this trial.Patients（fresh traumatic unilateral closed femoral shaft fractures AO 32-A,32-B type）meet the inclusion and exclusion criteria were randomly divided into two groups:the TXA group and the placebo group.Baseline characteristics of every patients were collected,such as age,gender,height,weight,limb,AO type of femoral shaft fracture.The level of HGB and HCT of every patient when admitted to hospital as well as the day before operation.The time from injury to operation was recorded.The TXA group took IV administration of 20 mg/kg of TXA 10 minutes before operation.The placebo group took 100 m L normal saline as a blank check.All the patients were treated with femoral intramedullary nail,and All operations were performed by the same surgical group.Time of operation and dominant blood loss during operation were recorded.The postoperative wound bleeding volume,HGB and HCT level in 3^rd day postoperative,perioperative blood transfusion,hospital stay,and thromboembolism at 7 days after operation were recorded.Complications such as infection and delayed healing were collected as well.Total dominant blood loss perioperative,hidden blood loss preoperative,total blood loss and total hidden blood loss were calculated according to the Nadler equation and the Gross equation.Results:The TXA group（mean and standard deviation,（13.10±2.00）days）has a reduced（t=2.848,P=0.01）length of hospital stay than the placebo group（（15.25±2.69）days）.The total blood loss in the TXA group（（768.11±180.68）m L）was significantly reduced（t=6.024,P<0.05）in comparison with that in the placebo group（（958.40±193.32）m L）.The total hidden blood loss in the TXA group（（595.86±191.26）m L）is fewer（t=5.589,P<0.05）than the placebo group（（772.79±197.17）m L）.The TXA group（（10.83±2.56）g/L）shows smaller decrease（t=2.938,P=0.008）in hemoglobin than the placebo group（14.86±5.05）g/L).There was no difference among the two groups with regard to the rates of transfusion（χ²=0.360,P=1.000）.There was no difference among the two groups with regard to the rates of deep vein thrombosis（χ²=0.229,P=1.000）or pulmonary embolism until 7th day after operation.Conclusions:The intravenous（IV）administration of TXA in patients treated with intramedullary fixation of femoral shaft fracture is safe and effective.TXA can reduce the blood loss during perioperative period,especially the hidden blood loss,and don’t increase the rate of transfusion and DVT.