Single tranexamic acid dose to reduce perioperative morbidity in primary total hip replacement: a randomised clinical trial.
BACKGROUND
Although prophylactic tranexamic acid (TXA) is a safe, low-cost option to reduce bleeding in patients undergoing total hip replacement (THR), its optimal dose and duration is unknown. We compared the safety and effectiveness of TXA given as either a single injection or continuous infusion in THR patients, hypothesising that a second TXA dose would not offer any clinical advantages over the single injection.


METHODS
One hundred and sixty-four patients undergoing unilateral THR were randomised. Exclusion criteria were history of thromboembolic events (TE), epilepsy, thrombophilia, and severe chronic renal failure. Patients received either a single dose of 30 mg/kg TXA on induction of surgery (one shot [OS] group), or a loading dose of 10 mg/kg TXA followed two hours later by a continuous infusion of 2 mg/kg per hour for 20 hours (one day [OD] group). The primary outcome was blood loss (BL) calculated from haematocrit levels. Secondary outcomes were mortality and TE events within 90 days postoperatively.


RESULTS
All patients completed treatment, with none lost to follow-up. Mean BL was 1107 ± 508 ml in Group OS and 1047 ± 442 ml in Group OD (p = 0.43). No patients were transfused prior to Day 10 postoperatively. At final follow-up, no patients had died, and there were no occurrences of major TE.


CONCLUSIONS
The 30 mg/kg TXA single shot was as safe as continuous infusion. As it is also less cumbersome, we recommend it as part of routine care in THR patients.
1 Department of Orthopaedic Surgery, Polyclinique de la Thiérache, Wignehies - France.
Hervé
H
Hourlier
Peter
P
Fennema
D000368:Aged; D000933:Antifibrinolytic Agents / Q000008:administration & dosage; D019644:Arthroplasty, Replacement, Hip; D016063:Blood Loss, Surgical / Q000401:mortality / Q000517:prevention & control*; D001803:Blood Transfusion / Q000706:statistics & numerical data; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D006801:Humans; D007262:Infusions, Intravenous; D007432:Intraoperative Period; D008297:Male; D009017:Morbidity / Q000639:trends; D019106:Postoperative Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D014148:Tranexamic Acid / Q000008:administration & dosage*; D016896:Treatment Outcome
D000933:Antifibrinolytic Agents; D014148:Tranexamic Acid