OBJECTIVE: Although there are still some controversies, large previous studies have confirmed that intravenous (i.v.) tranexamic acid (TXA) can effectively reduce blood loss and transfusions in total hip arthroplasty (THA) without increasing the risk of deep venous thrombosis. However, few studies have investigated the combination of i.v. and topical application of TXA in primary THA. The purpose of our current study is to examine whether i.v. combined with topical administration of TXA decreases postoperative blood loss and transfusion rates after THA. METHODS: From December 2013 to May 2014, all adult patients undergoing primary THA at our arthroplasty center were considered for inclusion in the present study. Included patients were randomly assigned to two groups by computer-generated list number: a TXA group and a placebo group. Patients in the TXA group received i.v. (15 mg/kg) combined with topical administration (1.0 g) of TXA during the THA procedure, and patients in the other group received the same dosage of normal saline both i.v. and topically. Our primary outcome measures were total blood loss (calculated using Gross's equation), hemoglobin, hematocrit and platelet concentration changes on the third postoperative day, the amount of drainage, the amount of intraoperative blood loss, the frequency of transfusion, and the number of blood units transfused. Secondary outcome measures were the length of postoperative stay, range of hip motion (measured by goniometer), Harris hip scores (HHS), and any perioperative complications or events such as infection, DVT or PE. Range of motion and HHS were measured at 3 week follow-up and compared with preoperative values. RESULTS: This trial included 100 patients (50 in each group). Patients in the TXA group had significantly higher postoperative hemoglobin (103 vs 87.7 g/dL, P < 0.01), lower hemoglobin changes (32.2 vs 44.9 g/dL, P < 0.01), higher postoperative hematocrit (0.32 vs 0.27 L/L, P < 0.01), lower hematocrit changes (0.1 vs 0.14 L/L, P < 0.01), lower total blood loss (822 vs 1100 mL, P = 0.004), lower drainage (117.8 vs 242.4 mL, P < 0.01), lower intraoperative blood loss (193.8 vs 288.2 mL, P < 0.01), and lower transfusion rate (2% vs 34%, P < 0.01) compared with those in the placebo group. No statistical difference was found in postoperative platelets between the two groups. There were no differences in perioperative complications or venous thromboembolism (VTE) events. CONCLUSIONS: The combined administration of i.v. and topical TXA resulted in a clinically relevant reduction in blood loss, compared with placebo group. No thromboembolic complications were observed. This randomized controlled trial supports the combined i.v. and topical administration of TXA in primary THA.
RCT Entities:
OBJECTIVE: Although there are still some controversies, large previous studies have confirmed that intravenous (i.v.) tranexamic acid (TXA) can effectively reduce blood loss and transfusions in total hip arthroplasty (THA) without increasing the risk of deep venous thrombosis. However, few studies have investigated the combination of i.v. and topical application of TXA in primary THA. The purpose of our current study is to examine whether i.v. combined with topical administration of TXA decreases postoperative blood loss and transfusion rates after THA. METHODS: From December 2013 to May 2014, all adult patients undergoing primary THA at our arthroplasty center were considered for inclusion in the present study. Included patients were randomly assigned to two groups by computer-generated list number: a TXA group and a placebo group. Patients in the TXA group received i.v. (15 mg/kg) combined with topical administration (1.0 g) of TXA during the THA procedure, and patients in the other group received the same dosage of normal saline both i.v. and topically. Our primary outcome measures were total blood loss (calculated using Gross's equation), hemoglobin, hematocrit and platelet concentration changes on the third postoperative day, the amount of drainage, the amount of intraoperative blood loss, the frequency of transfusion, and the number of blood units transfused. Secondary outcome measures were the length of postoperative stay, range of hip motion (measured by goniometer), Harris hip scores (HHS), and any perioperative complications or events such as infection, DVT or PE. Range of motion and HHS were measured at 3 week follow-up and compared with preoperative values. RESULTS: This trial included 100 patients (50 in each group). Patients in the TXA group had significantly higher postoperative hemoglobin (103 vs 87.7 g/dL, P < 0.01), lower hemoglobin changes (32.2 vs 44.9 g/dL, P < 0.01), higher postoperative hematocrit (0.32 vs 0.27 L/L, P < 0.01), lower hematocrit changes (0.1 vs 0.14 L/L, P < 0.01), lower total blood loss (822 vs 1100 mL, P = 0.004), lower drainage (117.8 vs 242.4 mL, P < 0.01), lower intraoperative blood loss (193.8 vs 288.2 mL, P < 0.01), and lower transfusion rate (2% vs 34%, P < 0.01) compared with those in the placebo group. No statistical difference was found in postoperative platelets between the two groups. There were no differences in perioperative complications or venous thromboembolism (VTE) events. CONCLUSIONS: The combined administration of i.v. and topical TXA resulted in a clinically relevant reduction in blood loss, compared with placebo group. No thromboembolic complications were observed. This randomized controlled trial supports the combined i.v. and topical administration of TXA in primary THA.