Topical Administration of Tranexamic Acid Plus Diluted- Epinephrine in young and middle-aged patients with femoral neck fracture: A Randomized Double-Blinded Controlled Trial

Abstract

Abstract Objective The objective of this trial was to evaluate the efficacy and safety of topical administration of tranexamic acid (TXA) combined with diluted-epinephrine (DEP) on perioperative blood loss and transfusion in young and middle-aged patients with femoral neck fracture who did not undergo drainage. Methods Sixty patients were enrolled in this trial. In the target group(TXA/DEP group: n=30;18 men and 22 women, mean age 41.36±12.17 years), the surgical sites were injected with 50 mL normal saline mixed with 1 g of TXA with 0.25 mg of DEP at a 1:200,000 dilution (TXA/DEP).In the control group, (TXA group: n=30; 11 men and 19 women; mean age: 43.70±14.63 years), the surgical site was injected with 50 mL normal saline containing 1 g of TXA alone. The main outcome measures were total blood loss(TBL),dominant blood loss(DBL),hidden blood loss(HBL), postoperative hemoglobin (Hb) levels, hematocrit(HCT) and activated partial thromboplastin time(APTT), the secondary measures included transfusion requirements, Harris hip score, satisfactory degree and perioperative complications. Results The results showed that topical combined administration significantly reduced the decrease of hemoglobin among patients in the TXA/DEP group, measured on postoperative day 1 at 123.43±6.84 g/L vs. 118.33±6.30 g/L (TXA/DEP group vs. TXA group) , day 3 as 104.36±8.01 g/L vs. 96.83±7.56g/L, and day 5 as 115.96±6.49 g/L vs. 110.03±7.85 g/L, respectively (p<0.05). The mean HCT levels among patients in the TXA/DEP group were significantly higher than among those in the TXA group, measured on postoperative day 1 at 34.83±1.96% vs. 33.03±2.78% , day 3 as 32.40±2.83% vs. 30.83±2.65%, and day 5 as 38.63±1.56% vs. 37.06±1.99%, respectively (p<0.05). TBL, DBL, and HBL were also significantly reduced in the TXA/DEP group vs. the TXA group, measured at 333.40±42.19 ml vs. 396.30±53.54 ml, 72.33±16.28 ml vs. 91.86±20.10 ml, and 261.06±36.76 ml vs. 304.43±48.68 ml. 2 patients (6.66%) from the TXA/DEP group and 9 (30.00%) from the TXA group received blood transfusions, respectively (p<0.05).The Harris scores and satisfactory degrees among patients in the TXA/DEP group were significantly higher than among those in the TXA group, measured on postoperative day 21, respectively (p<0.05),which did not significantly differ from one another on postoperative3 months, respectively(P＞0.05).Furthermore, four cases in the TXA/DEP group and seven in the TXA group were diagnosed with subcutaneous ecchymosis, five cases in the TXA/DEP group and nine in the TXA group were diagnosed with deep vein thrombosis, and one case in the TXA/DEP group was diagnosed with adverse medicine reaction, those differences did not reach statistical significance (p>0.05). Conclusion Topical administration of TXA with DEP was safer and more effective in reducing blood loss and transfusion than the administration of TXA alone in treating young and middle-aged patients with femoral neck fracture, without increasing the risk of perioperative complications.