[Efficacy and safety of intravenous combined with topical administration of tranexamic acid in reducing blood loss after intramedullary fixation of intertrochanteric femoral fractures]

Abstract

Objective: To investigate the efficacy and safety of intravenous combined with topical administration of tranexamic acid (TXA) in reducing blood loss after intramedullary fixation of intertrochanteric femoral fractures by a prospective controlled trial.

Methods: Patients with intertrochanteric femoral fractures, who were admitted for intramedullary fixation between June 2015 and July 2019, were selected as the study subjects, 120 of whom met the selection criteria. The patients were randomly assigned to 3 groups: intravenous administration group (group A, 41 cases), topical administration group (group B, 40 cases), and combined administrations group (group C, 39 cases). In group A, 4 patients occurred deep vein thrombosis of lower extremity before operation, 1 patient died of myocardial infarction on the 5th day after operation, and 1 patient developed severe pulmonary infection after operation. In group B, 2 patients occurred deep vein thrombosis of lower extremity before operation and 1 patient had iatrogenic fracture during operation. In group C, 3 patients occurred deep vein thrombosis of lower extremity before operation and 1 patient developed pulmonary infection before operation and gave up surgical treatment. All the above patients were excluded from the study, and the remaining 107 cases were included in the analysis, including 35, 37, and 35 cases in groups A, B, and C, respectively. There was no significant difference in gender, age, height, body mass, injury cause, fracture side and type, the interval between injury and operation, and preoperative hemoglobin (Hb), hematocrit between groups ( P>0.05). Intraoperative TXA (15 mg/kg) was injected intravenously in group A at 30 minutes before operation, and 1 g of TXA was injected into the medullary cavity in group B after the proximal femur was grooted and before the intramedullary nail implantation, respectively. TXA was given in group C before and during operation according to the administration methods and dosage of groups A and B. Total blood loss, maximum Hb decrease, blood transfusion rate, operation time, fracture healing time, and the incidence of complications were recorded and compared between groups. The hip joint function were evaluated by Harris score.

Results: There was no significant difference in operation time between groups ( P>0.05). The total blood loss, the maximum Hb decrease, and the blood transfusion rate in group B were the highest, followed by group A and group C, and the differences between groups were significant ( P<0.05). No incision infection or pulmonary embolism occurred in the 3 groups after operation. The incidence of anemia in group C was significantly lower than that in groups A and B, the difference was significant ( P<0.05). There was no significant difference in the incidence of subcutaneous hematoma, aseptic exudation, and deep vein thrombosis of lower extremity between groups ( P>0.05). All patients in the 3 groups were followed up 8-35 months, with an average of 16.2 months. The fracture healing time of groups A, B, and C was (6.12±1.78), (5.89±1.63), and (5.94±1.69) months, respectively, and there was no significant difference between groups ( P>0.05). At last follow-up, the Harris scores of the hip joints in groups A, B, and C were 83.18±7.76, 84.23±8.01, and 85.43±8.34, and the difference was not significant ( P>0.05).

Conclusion: Preoperative intravenous injection combined with intraoperative topical application of TXA can effectively reduce blood loss and blood transfusion after intramedullary fixation of femoral intertrochanteric fracture, without increasing the risk of deep vein thrombosis, and the efficacy is better than that of intravenous injection or topical administration.

Keywords: Femoral intertrochanteric fracture; blood loss; intramedullary fixation; tranexamic acid.