Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial.
Eur J Anaesthesiol
; 41(3): 217-225, 2024 Mar 01.
Article
em En
| MEDLINE
| ID: mdl-38214552
ABSTRACT
BACKGROUND:
Oral as compared to intravenous tranexamic acid (TXA) is an attractive option, in terms of cost and safety, to reduce blood loss and transfusion in total hip arthroplasty. Exclusion criteria applied in the most recent randomised trials may have limited the generalisability of oral tranexamic acid in this indication. Larger and more inclusive studies are needed to definitively establish oral administration as a credible alternative to intravenous administration.OBJECTIVES:
To assess the noninferiority of oral to intravenous TXA at reducing intra-operative and postoperative total blood loss (TBL) in primary posterolateral approached total hip arthroplasty (PLTHA).DESIGN:
Noninferiority, single centre, randomised, double-blind controlled study.SETTING:
Patients scheduled for primary PLTHA. Data acquisition occurred between May 2021 and November 2022 at the University Hospital of Liège, Belgium. PATIENTS Two hundred and twenty-eight patients, randomised in a 1ââ1 ratio from a computer-generated list, completed the trial.INTERVENTIONS:
Administration of 2âg of oral TXA 2âh before total hip arthroplasty and 4âh after incision (Group oral) was compared to the intravenous administration of 1âg of TXA 30âmin before surgery and 4âh after incision (Group i.v.). MAIN OUTCOMEMEASURES:
TBL (measured intra-operative and drainage blood loss up to 48âh after surgery, primary outcome), decrease in haemoglobin concentration, D-Dimer at day 1 and day 3, transfusion rate (secondary outcomes).RESULTS:
Analyses were performed on 108 out of 114 participants (Group i.v.) and 104 out of 114 participants (Group oral). Group oral was noninferior to Group i.v. with regard to TBL, with a difference between medians (95% CI) of 35âml (-103.77 to 33.77) within the noninferiority margins. Median [IQR] of estimated TBL was 480âml [350 to 565] and 445âml [323 to 558], respectively. No significant interaction between group and time was observed regarding the evolution of TBL and haemoglobin over time.CONCLUSIONS:
TXA as an oral premedication before PLTHA is noninferior to its intravenous administration regarding peri-operative TBL. TRIAL REGISTRATION European Clinical Trial Register under EudraCT-number 2020-004167-29 ( https//www.clinicaltrialsregister.eu/ctr-search/trial/2020-004167-29/BE ).
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ácido Tranexâmico
/
Perda Sanguínea Cirúrgica
/
Artroplastia de Quadril
Tipo de estudo:
Clinical_trials
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Eur J Anaesthesiol
Ano de publicação:
2024
Tipo de documento:
Article