A comparison of indobufen and low-molecular-weight heparin in the prevention of deep vein thrombosis in patients after total hip arthroplasty: a prospective randomized controlled study

Objective: This was a prospective, randomized, controlled study to explore the anti-coagulation effectiveness and drug safety of indobufen in patients with total hip arthroplasty. Methods: Patients with avascular necrosis of the femoral head (AVN), hip traumatic arthritis (OA), and developmental dysplasia of the hip (DDH) who had an indication for total hip arthroplasty (THA) and who were admitted to our hospital from January to December 2017 were analyzed in this study. This study was a prospective, single-center, randomized controlled study. Eligible patients were randomized and divided into two groups: the LMWH group and the INDO group. For the LMWH group, low-molecular-weight heparin calcium was given by subcutaneous navel injection at a dose of 4100u per day. For the INDO group, indobufen was administered orally at a dose of 200 mg bid. All the anticoagulants were continuously used no fewer than 35 days postoperatively. The primary outcomes were morbidity and the severity of deep vein thrombosis (DVT). Results: A total of 216 patients were available. 50 (23.15%) patients developed DVTs. In the LWMH group, 28 patients had DVTs, including 21 patients with DVTs in their intermuscular veins, 5 patients with DVTs in their peroneal and posterior tibial veins, 1 patient with DVTs in his or her popliteal veins, and 1 patient with DVTs in his or her femoral veins. In the INDO group, 22 patients had DVTs, including 19 patients with DVTs in their intermuscular veins, 3 patients with DVTs in their peroneal and posterior tibial veins, but no patient had DVTs in their popliteal or femoral veins. The morbidity and severity showed no statistical differences between the two groups. The volume of drainage was 671.62 +/- 273.23 ml in the first two days postoperatively in the LWMH group, and 818.82 +/- 346.22 ml in the INDO group. The volume of drainage in the INDO group was significantly higher than in the LWMH group (P = 0.001). The fall in blood hemoglobin within the first 10 days postoperatively was 8.25 +/- 5.35 g/L in the LWMH group and 9.63 +/- 6.23 g/L in the INDO group respectively, with no statistical difference (P = 0.136). In this study, no major bleeding event occurred in either group. In the LMWH group, there was 1 patient with coagulation system complications (ecchymosis), 1 patient with other complications (erythra). In the INDO group, there were 3 patients with digestive complications (nausea, vomiting, abdominal pain, and distention), but no other complication was found. The morbidity and classification showed no statistical differences between the two groups (chi(2) = 4.970, P = 0.174). Conclusions: Compared with LMWH, indobufen had a similar effect on the prevention of DVTs in patients with primary THA. The morbidity and severity showed no significant differences between the two groups. In addition, no major bleeding events occurred in this study.