Vol.:(0123456789) 1 3 Archives of Orthopaedic and Trauma Surgery https://doi.org/10.1007/s00402-018-3089-4 ORTHOPAEDIC SURGERY Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement: efcacy and safety of fbrin sealant and tranexamic acid. A randomised controlled clinical trial (TRANEXFER study) Marcos Jordan 1  · Xavier Aguilera 1  · José Carlos González 1  · Pablo Castillón 2  · Mónica Salomó 3  · José Antonio Hernández 4  · Leonardo Ruiz 4  · José Maria Mora 5  · Pilar Camacho‑Carrasco 6  · Salvi Prat‑Fabregat 6  · Alba Bosch 7  · Ainhoa Rodriguez‑Arias 8  · María José Martínez‑Zapata 9  on behalf of the TRANEXFER Group Received: 6 July 2018 © Springer-Verlag GmbH Germany, part of Springer Nature 2018 Abstract Introduction We assessed the efcacy of fbrin 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) 10 ml of FS, (2) 1 g of topical TXA, both administered at the end of the surgery, and (3) usual hae- mostasis (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 (148.6 ml, SD 122.7 in TXA; 168.2 ml, SD 137.4 in FS; and 201.5 ml, SD 166.5 in control group) without achieving statistical signifcance (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 signifcance (p = 0.341). There were no complications or adverse efects 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 signifcantly reduce either postoperative blood loss or transfusion rate, compared with a group that only received usual haemostasis. Keywords Hip fracture · Tranexamic acid · Fibrin sealant · Randomised clinical trial Introduction Proximal femoral fractures are usually caused by high- energy trauma in young adults, but by a low-energy trauma in the elderly [1]. This condition occurs more often in the elderly, presenting one of the highest incidences of morbid- ity and mortality. Specifcally, mortality incidence ranges from 18 to 33% per year [2]. Age, sex, dementia, and frailty are associated with increased mortality [2]. Despite the advances in surgical techniques and materials in the treatment of femoral fractures, the blood loss causes anaemia and increases perioperative morbidity and mortality [3–5]. Pharmacological and non-pharmacological strategies should be applied to reduce bleeding and to avoid transfu- sions. One strategy is the intraoperative administration of topical or intravenous haemostatic agents. Tranexamic acid (TXA) inhibits fbrinolysis by blocking the lysine-binding sites on plasminogen, and facilitates the coagulation pro- cess [6]. Fibrin Sealant (FS) is a biological adhesive which initiates the fnal stages of coagulation. It is derived from the transformation of fbrinogen in fbrin by thrombin [7]. Several clinical trials and meta-analyses have studied the TRANEXFER Group memebers list are given in “Acknowledgement” section. * María José Martínez-Zapata mmartinezz@santpau.cat Extended author information available on the last page of the article