The demand for blood transfusion in orthopaedic surgery has increased during the last few decades. Despite exhaustive controls, allogenic transfusion is not risk-free, with regards to both the transmission of infectious and contagious diseases and reactions to transfusions, or the immunomodulator effect which may increase the risk of post-operative infection. Added to this is the fact that transfusion increases hospital stay and healthcare costs. As a result, a series of measures have been developed, aimed at reducing to a maximum the need for blood transfusions. Pharmacological measures, such as tranexamic acid (TXA), marketed as Amchafibrin®, which is a synthetic derivative of lysine with a pure antifibrinolytic action,1–7 are among these.

There is scientific evidence reported in the literature on the use of tranexamic acid as a means of saving on transfusions in total hip arthroplasty (THA), due to its efficacy and safety in randomised studies and meta-analysis, but its use to this end remains controversial in Spain.8–10 For this reason we have designed this study, with which we have tried to achieve a higher level of evidence for the use of this drug in our specialty.

The main aim of this study was to examine the effectiveness of tranexamic acid as a method of reducing perioperative bleeding in patients who had undergone primary THA. Our secondary objective was to evaluate how this drug affected homologous blood transfusion needs, and to assess its safety.

A prospective, randomised study was conducted which included 134 consecutive patients, diagnosed with coxarthrosis and who had been treated with THA by 5 surgeons experienced in this surgery, under spinal anaesthesia, in our hospital in 2014. To ensure randomisation, the hospital clinical file number was used, assigned in order of patient entry, with the result that even numbers were assigned to group A and odd numbers to group B. Both groups were paired regarding variables which could affect the study, such as the comorbidity measured by the Charlson index, grade ASA, IMC, age, gender and pre-surgical analytical parameters, including Hb and Hct values, the 2 groups thus being homogenous prior to intervention. The administration of tranexamic acid was performed by the anaesthesia team prior to surgery. No pre-surgical preparation or anaesthesia procedure was performed to try to reduce intraoperative bleeding. Careful surgical technique and haemostasis were employed as was a direct measurement of intraoperative bleeding. The implant model used was the same in all cases (Furlong® uncemented prosthesis). Minimum patient follow-up was 12 months.

Out of the 134 patients who underwent surgery, 67 received treatment with TXA. Of the total patients included in the study 75 were women, which accounted for 66%, with a mean age of 3.26 years older than the men. Presurgical Hb and Hct levels were similar in both groups. In the group which received TXA an Hb level of 1422 and a Hct level of 41.99 was present whilst in the control group the levels were Hb 13.97 and Hct 41.34 (Table 1).

Time in surgery and hospital stay days were also similar in both groups (Table 2).

During the first 48h after surgery, levels of bleeding from drains in the control group were higher (660cc) than those in patients treated with TXA (550cc) (p=0.101), although the differences were only statistically significant (p=0.01) compared with levels collected by draining after 24h (400cc in the group treated with TXA compared with 550 of the control group) (Table 2 and Fig. 1).

Figure 1.

Diagram of mean volume of bleeding collected by the drain system depending on the group.

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Post-surgical Hb and Hct levels were statistically lower (p<0.001) in the control group (Hb [9.07±1.24] and Hct [27.42±4.84]) compared with the group treated with TXA (Hb [11.82±1.45] and Hct [31.55±5.02]) (Fig. 2).

Figure 2.

Diagram of pre and post-surgical Hb and Hct levels boxes depending on the study group.

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Statistically significant differences were found (p<0.001) regarding the need for transfusion and the group to which the patients belonged. Out of 134 patients who required transfusion 20 (14.9%), 17 of them (85%) were patients belonging to the control group. The transfusion percentage per group was 7% in the group treated with TXA and 25.37% in the control group, which constitutes a difference of 20.9 percentage points (Fig. 3).

Figure 3.

Diagram of bars of the need for allogenic blood transfusion (ABT) according to the study group.

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There were no thromboembolic events in any of the groups.

The essential findings from this study were that the administration of TXA reduces postoperative bleeding, especially in non-visible losses, and transfusion requirements of patients who have undergone total hip arthroplasty. It equally proves to be a safe procedure, as there is no complication regarding its administration. This is the first article published in Spain in which the use and usage complications of TXA in THA have been studied prospectively.

Our findings concur with those reported in the literature to date. In the last 5 years 5 meta-analyses have been published on the use of TXA in THA,15–19 2 of them include joint procedures of THA and ATR17,18 and the other 3 focus on THA.15,16,19 Of the meta-analyses that of Moskal et al.15 is of note, published in 2016, and which analyses the effects of intravenous administration of TXA in patients who had undergone THA in 16 studies, all of them prospective, randomised and controlled. An analysis of 993 surgical interventions was therefore made. This work concluded that the patients treated with TXA bled less and received fewer transfusions than the control group. Other publications such as the Seville Document and the Guidelines from the European Society of Anaesthesiology20–22 suggested the use of TXA in COT, with a weak recommendation supported by high quality proofs. Furthermore, with regards to ATR about which more publications exist, the American Academy of Orthopaedic Surgeons publishes a practical guide on knee arthrosis with recommendation of TXA use in patients with no known contraindications.22 Use of TXA in orthopaedic surgery in Spain is increasing, and several articles have been published on its use in the country.23 The article published by Sanz-Reig et al. in 201424 is outstanding in this regard. This was a prospective and randomised study in which the use of TXA in knee replacement surgery was proven to reduce transfusion needs. The latest article published in Spain by Castro et al. (2016) is a prospective and randomised study, although the control group is retrospective, in which the efficacy of the intravenous administration of TXA was studied (on a group with a dose of 1g intraoperatively and 1g 3h after surgery. The other group was administered with 2g intravenously 30min before), in patients who underwent both ATR and THA.9

We found no significant increase in complications in the first group treated with TXA compared with the control group. These data coincide with those published in the literature, except with regards to TVP, where there is no consensus due the fact that in several studies, such as the meta-analysis of Moskal et al.,15 it is clear that there is a greater increase in the TVP rate in patients who received TXA, but in others, however, no differences were found in the cases of TVP.9,24 For this reason its use in orthopaedic surgery is still controversial. This discordance may be due to the different study sample sizes.

Controversy continues to arise with regards to dose and administration route. Several studies were published last year which compared different guidelines, dose and administration routes, concluding that they were all effective,9,25–27 and we thus continue without any conclusive scientific evidence today as to what is the ideal for obtaining maximum benefit with the lowest risk to the patient. With regards to time in surgery, it is notable that in the majority of publications9,28 this is not specified, not even if the differences between both groups had been studied according to this parameter. This aspect appears to have an effect on greater intraoperative blood loss. However, although in the present study no direct relationship was found between time in surgery and the need for transfusion, nor in the lowering of post-surgical Hb levels, but there is a trend which was not statistically significant. We must, however, not forget that correct perioperative management includes not only the use of antifibrinolytic drugs but many other factors, including pre-operative calculation of transfusion requirements, individualisation of patient needs, the use of self-recovery drains and correct anaesthetic and surgical techniques and they should be included in a programme to prevent allogenic blood transfusion.20,22,29

There are several limitations to this study. One of them is the sample size (limited to 134 patients). Secondly, TVP diagnosis was made with clinical follow-up, indicating only Doppler ultrasound in cases in which there was clinical suspicion, which is an attitude that is more similar to daily clinical practice, but no Doppler ultrasound was systematically performed to detect the cases of subclinical TVP. The strong points of this study are that this is a prospective, randomised and controlled study and that the surgical team were stable, as was the nursing team and the laboratory team. Strict written compliance of perioperative protocol and measurements were thus achieved, with no bias of untrained staff present. Surgeries were also consecutive and with very similar demographics, thus constituting homogenous groups.

The administration of TXA has proven to be a safe, effective method for reducing non-visible losses and through drains 24h after patients underwent THA. Transfusion requirements were also lower in the group treated with TXA compared with the control group.

Level of evidence II.

The authors have no conflict of interests to declare.