What did the study look at?
Tranexamic acid (TXA) is a drug that slows the breakdown of blood clots and is used to reduce blood loss during and after surgery. The authors note that its use in orthopaedics is growing, but that there are concerns it might increase the risk of venous thromboembolism (VTE), such as clots in the leg veins (deep vein thrombosis) or clots travelling to the lungs (pulmonary embolism).
The aim was to assess the safety of TXA in lower limb orthopaedic operations, including hip and knee replacement, fracture treatment and sports injuries, by pooling high-level evidence.
How was it done?
This is a meta-analysis of randomised controlled trials: no new patient data were collected; instead, the results of previously published trials were combined statistically.
- The PubMed, Web of Science and Cochrane Library databases were searched in January 2020.
- English-language randomised controlled trials in lower limb orthopaedic surgery that compared a TXA group with a control group and reported VTE complications were included.
- Intravenous, intra-articular (into the joint) and oral TXA were all included, with no exclusions based on dose or timing.
- Screening was done by two independent reviewers, and a statistical method suited to rare events (Peto's method) was used.
What did it find?
- Of 1,797 records, 140 trials were analysed, with 9,067 patients receiving TXA and 6,592 controls. Of these trials, 82 concerned knee replacement, 41 hip replacement and 17 other operations (anterior cruciate ligament reconstruction, intertrochanteric fractures and meniscectomy).
- Overall, the VTE rate was 2.4% with TXA and 2.8% in controls, a non-significant difference (p = 0.291).
- Rates were 3.1% and 3.9% in knee replacement (p = 0.189), 1.1% in both groups in hip replacement (p = 0.769), and 2.6% and 2.4% in other operations (p = 0.827).
- No difference was found by route either: intravenous 2.7% vs 2.6%; intra-articular 2.3% vs 2.8%; oral 1.0% vs 2.8%.
- Some 54% of the trials had been published after 2015.
The authors' conclusion
The authors conclude that TXA did not increase the risk of VTE in lower limb orthopaedic surgery, regardless of the route of administration, and that this finding was consistent across knee replacement, hip replacement and other procedures. They also highlight the wide variation in dose, timing and duration in the literature and the need to standardise administration protocols.
Limitations
- The included trials differed in TXA dose and timing.
- VTE screening methods and anticlotting prophylaxis were not consistent across trials.
- Only VTE complications were analysed; other complications such as infection were too infrequent to evaluate.
- The results apply only to the types of patients included in the trials. High-risk patients, such as those with a history of clots or ischaemic events or with vascular stents, were commonly excluded.
Reference
Reale D, Andriolo L, Gürsoy S, Bozkurt M, Filardo G, Zaffagnini S. 2021. Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials. BioMed Research International. 2021:6961540. Licence: CC BY 4.0.
DOI: 10.1155/2021/6961540
Free full text: PubMed Central PMC7834786
This article summarises a published scientific paper for general information; it does not replace an examination or a personal medical assessment. Please consult your doctor about your symptoms.
