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)
Por:
Jordan, M, Aguilera, X, Gonzalez, JC, Castillon, P, Salomo, M, Hernandez, JA, Ruiz, L, Mora, JM, Camacho-Carrasco, P, Prat-Fabregat, S, Bosch, A, Rodriguez-Arias, A, Martinez-Zapata, MJ, De Caso, J, Carrera, I, Milian, A, Pulido, MC, Valera, M, Crusi, X, Nunez, JAF, Bage, AC, Alavedra, A, Novellas, M, Crespo, FA, Urrutia, G, Canovas, E
Publicada:
1 may 2019
Resumen:
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.
Filiaciones:
Jordan, M:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Aguilera, X:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Gonzalez, JC:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Castillon, P:
Hosp Univ Mutua Terrassa, Orthoped & Traumatol Serv, Barcelona, Spain
Salomo, M:
Consorci Hosp Parc Tauli, Orthoped & Traumatol Serv, Barcelona, Spain
Hernandez, JA:
Hosp Badalona Germans Trias & Pujol, Orthoped & Traumatol Serv, Barcelona, Spain
Ruiz, L:
Hosp Badalona Germans Trias & Pujol, Orthoped & Traumatol Serv, Barcelona, Spain
Mora, JM:
Hosp Univ Terrassa, Orthoped & Traumatol Serv, Barcelona, Spain
Camacho-Carrasco, P:
Hosp Clin Barcelona, Orthoped & Traumatol Serv, Barcelona, Spain
Prat-Fabregat, S:
Hosp Clin Barcelona, Orthoped & Traumatol Serv, Barcelona, Spain
Bosch, A:
Hosp Santa Creu & Sant Pau, Banc Sang & Teixits Catalunya, Barcelona, Spain
Rodriguez-Arias, A:
Hosp Santa Creu & Sant Pau, Pharm Serv, Barcelona, Spain
Martinez-Zapata, MJ:
IIB St Pau, CIBERESP, Publ Hlth & Clin Epidemiol Serv, Iberoamer Cochrane Ctr, Barcelona, Spain
De Caso, J:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Carrera, I:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Milian, A:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Pulido, MC:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Valera, M:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Crusi, X:
Hosp Santa Creu & Sant Pau, Orthoped & Traumatol Serv, Barcelona, Spain
Nunez, JAF:
Hosp Santa Creu & Sant Pau, Anesthesiol Serv, Barcelona, Spain
Bage, AC:
Hosp Univ Mutua Terrassa, Orthoped & Traumatol Serv, Barcelona, Spain
Alavedra, A:
Consorci Hosp Parc Tauli, Orthoped & Traumatol Serv, Barcelona, Spain
Novellas, M:
Hosp Univ Terrassa, Anesthesiol Serv, Barcelona, Spain
Crespo, FA:
Hosp Univ Mutua Terrassa, Orthoped & Traumatol Serv, Barcelona, Spain
Urrutia, G:
IIB St Pau, CIBERESP, Publ Hlth & Clin Epidemiol Serv, Iberoamer Cochrane Ctr, Barcelona, Spain
Canovas, E:
IIB St Pau, Iberoamer Cochrane Ctr, Barcelona, Spain
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