Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement: efficacy and safety of fibrin sealant and tranexamic acid. A randomised controlled clinical trial (TRANEXFER study)

Introduction We assessed the efficacy of fibrin sealant (FS) and tranexamic acid (TXA) administered topically in patients with a hip fracture treated with prosthetic replacement. Materials and methods Parallel, multicentre, open label, randomised, clinical trial. We compared three interventions to reduce blood loss: (1) 10ml of FS, (2) 1g of topical TXA, both administered at the end of the surgery, and (3) usual haemostasis (control group). The main outcome was blood loss collected in drains. Other secondary variables were total blood loss, hidden blood loss, transfusion rate, average hospital stay, complications, adverse events, and mortality. Results A total of 158 patients were included, 56 in the FS group, 52 in the TXA group, and 50 in the control group. The total amount of blood collected in drains was lower in the TXA group (148.6ml, SD 122.7 in TXA; 168.2ml, SD 137.4 in FS; and 201.5ml, SD 166.5 in control group) without achieving statistical significance (p=0.178). The transfusion rate was lower in the TXA group (32.7%), compared with FS group (42.9%) and control group (44.0%), without statistical significance (p=0.341). There were no complications or adverse effects related to the evaluated interventions. Conclusions The use of TXA and FS administered topically prior to surgical closure in patients with a sub-capital femoral fracture undergoing arthroplasty did not significantly reduce either postoperative blood loss or transfusion rate, compared with a group that only received usual haemostasis.