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)

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). Jordan, M., Aguilera, X., González, J. C., Castillón, P., Salomó, M., Hernández, J. A., Ruiz, L., Mora, J. M., Camacho-Carrasco, P., Prat-Fabregat, S., Bosch, A., Rodriguez-Arias, A., Martínez-Zapata, M. J., & TRANEXFER Group Archives of Orthopaedic and Trauma Surgery, December, 2018.
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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) 10 ml of FS, (2) 1 g 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 (148.6 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 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.

@article{jordan_prevention_2018,
	title = {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)},
	issn = {1434-3916},
	shorttitle = {Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement},
	doi = {10.1007/s00402-018-3089-4},
	abstract = {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) 10 ml of FS, (2) 1 g 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 (148.6 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 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.},
	language = {eng},
	journal = {Archives of Orthopaedic and Trauma Surgery},
	author = {Jordan, Marcos and Aguilera, Xavier and González, José Carlos and Castillón, Pablo and Salomó, Mónica and Hernández, José Antonio and Ruiz, Leonardo and Mora, José Maria and Camacho-Carrasco, Pilar and Prat-Fabregat, Salvi and Bosch, Alba and Rodriguez-Arias, Ainhoa and Martínez-Zapata, María José and {TRANEXFER Group}},
	month = dec,
	year = {2018},
	pmid = {30539285},
	keywords = {Article, COT, Fibrin sealant, Hip fracture, Randomised clinical trial, Tranexamic acid}
}

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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 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 (148.6 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 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.","language":"eng","journal":"Archives of Orthopaedic and Trauma Surgery","author":[{"propositions":[],"lastnames":["Jordan"],"firstnames":["Marcos"],"suffixes":[]},{"propositions":[],"lastnames":["Aguilera"],"firstnames":["Xavier"],"suffixes":[]},{"propositions":[],"lastnames":["González"],"firstnames":["José","Carlos"],"suffixes":[]},{"propositions":[],"lastnames":["Castillón"],"firstnames":["Pablo"],"suffixes":[]},{"propositions":[],"lastnames":["Salomó"],"firstnames":["Mónica"],"suffixes":[]},{"propositions":[],"lastnames":["Hernández"],"firstnames":["José","Antonio"],"suffixes":[]},{"propositions":[],"lastnames":["Ruiz"],"firstnames":["Leonardo"],"suffixes":[]},{"propositions":[],"lastnames":["Mora"],"firstnames":["José","Maria"],"suffixes":[]},{"propositions":[],"lastnames":["Camacho-Carrasco"],"firstnames":["Pilar"],"suffixes":[]},{"propositions":[],"lastnames":["Prat-Fabregat"],"firstnames":["Salvi"],"suffixes":[]},{"propositions":[],"lastnames":["Bosch"],"firstnames":["Alba"],"suffixes":[]},{"propositions":[],"lastnames":["Rodriguez-Arias"],"firstnames":["Ainhoa"],"suffixes":[]},{"propositions":[],"lastnames":["Martínez-Zapata"],"firstnames":["María","José"],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["TRANEXFER Group"],"suffixes":[]}],"month":"December","year":"2018","pmid":"30539285","keywords":"Article, COT, Fibrin sealant, Hip fracture, Randomised clinical trial, Tranexamic acid","bibtex":"@article{jordan_prevention_2018,\n\ttitle = {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)},\n\tissn = {1434-3916},\n\tshorttitle = {Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement},\n\tdoi = {10.1007/s00402-018-3089-4},\n\tabstract = {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.\nMATERIALS AND METHODS: Parallel, multicentre, open label, randomised, clinical trial. 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