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 1 : 1 ratio from a computer-generated list, completed the trial.

INTERVENTIONS 

Administration of 2 g of oral TXA 2 h before total hip arthroplasty and 4 h after incision (Group oral) was compared to the intravenous administration of 1 g of TXA 30 min before surgery and 4 h after incision (Group i.v.).

MAIN OUTCOME MEASURES 

TBL (measured intra-operative and drainage blood loss up to 48 h 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 35 ml (-103.77 to 33.77) within the noninferiority margins. Median [IQR] of estimated TBL was 480 ml [350 to 565] and 445 ml [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).