|Year : 2016 | Volume
| Issue : 3 | Page : 121-122
Commentary on "clinical efficacy of tranexamic acid administration via different routes during total hip arthroplasty: study protocol for a prospective randomized controlled trial"
Ido Badash, Brian Wu M.D.
Keck School of Medicine of University of Southern California (USC), Los Angeles, CA, USA
|Date of Web Publication||31-Aug-2016|
Keck School of Medicine of University of Southern California (USC), Los Angeles, CA
Source of Support: None, Conflict of Interest: None
Perioperative blood loss is a major complication of total hip arthroplasties. The use of tranexamic acid (TXA) is considered during total hip arthroplasties for its antifibrinolytic effects, reducing blood loss and anemia following these surgeries. In order to compare the efficacy of different forms of TXA administration on reducing blood loss, Zhou et al. have designed a randomized, controlled, double-blinded clinical trial comparing the use of intravenous TXA versus topical TXA administration. By employing a large sample size and an effective paired study design, the protocol of Zhou et al. may be effective in producing significant results on the relative efficacy of these two forms of TXA administration for reducing blood loss. This commentary addresses the strengths and drawbacks of this protocol, while also highlighting potential areas for improvement. With corrections, the study could prove clinically valuable to both patients and surgeons, since the use of topical TXA may result in fewer thromboembolic complications than intravenous administration.
Keywords: total hip arthroplasty; tranexamic acid; thromboembolism
|How to cite this article:|
Badash I, Wu B. Commentary on "clinical efficacy of tranexamic acid administration via different routes during total hip arthroplasty: study protocol for a prospective randomized controlled trial". Clin Trials Orthop Disord 2016;1:121-2
|How to cite this URL:|
Badash I, Wu B. Commentary on "clinical efficacy of tranexamic acid administration via different routes during total hip arthroplasty: study protocol for a prospective randomized controlled trial". Clin Trials Orthop Disord [serial online] 2016 [cited 2020 Apr 10];1:121-2. Available from: http://www.clinicalto.com/text.asp?2016/1/3/121/189515
Perioperative blood loss is a major clinical barrier associated with total hip arthroplasties (THA) (Walker et al., 1997). The use of tranexamic acid (TXA) is considered during THA for its antifibrinolytic effects, reducing blood loss and the need for blood transfusion following hip replacement. However, there are still concerns in the orthopedic community about the systemic thromboembolic complications of intravenous TXA use, including deep vein thrombosis, pulmonary embolism, myocardial infarctions and cerebrovascular accidents (Gillette et al., 2013). There is some evidence in the literature that topical administration of TXA is also effective at reducing postoperative blood loss, but with a lower incidence of thromboembolic complications (Emara et al., 2014). Thus, the study designed by Zhou et al. (2016), which aims to determine the relative efficacy of topical TXA administration versus intravenous administration on reducing postoperative blood loss, will yield clinically significant information for orthopedic surgeons who wish to reduce blood loss following THA but have concerns about the systemic effects of intravenous TXA administration.
There are a number of studies investigating the efficacy of various forms of TXA administration, but the study protocol created by Zhou et al. (2016) has a number of strengths that may yield additional significant and clinically valuable results on the topic (Wei and Wei, 2014; Danninger and Memtsoudis, 2015; North et al., 2016). First, the study is designed to provide level 1 evidence as a randomized, controlled, double-blinded design that will reduce the presence of selection and reporting biases. Additionally, the authors include a power analysis suggesting that their sample size of 58 subjects per study group should be effective in yielding statistically significant results. Finally, the study's 1:1:1 paired method for analyzing placebo versus intravenous versus topical administration groups will be effective for reducing variability between the groups and further reducing the risk of confounding. The 1:1:1 paired method is not common in the literature, but with effective pairing assignments could lead to statistically significant results, providing further high-level evidence in investigating the efficacy of variable TXA administration.
Although this randomized controlled study protocol is well designed, there are questions about the study protocol that the authors should address. Importantly, the authors state that they will use the 1:1:1 paired method for dividing subjects, but do not present any information on how the pairing of subjects will be performed. Additionally, the authors intend to measure blood loss by making hematocrit measurements prior to surgery and at postoperative day 3. Other studies, however, have found it effective to measure blood loss at various intervals after surgery (24 hours, 48 hours and 5 days after surgery), and used the lowest postoperative levels to measure changes (Gomez-Barrena et al., 2014). It is unclear why the authors intend to measure hematocrit solely at day 3 following surgery, since including other intervals will generate a more convincing estimate of overall blood loss.
The study's actual method for blood loss measurement represents another area for improvement. In their protocol, Zhou et al. state that they will calculate total blood loss according to erythrocyte changes between preoperative levels and those following surgery. They intend to use the Gross Equation, which utilizes a linear formula to approximate the logarithmic dilution of patient blood through red blood cell loss (Gross, 1983). However, this method does not involve hemoglobin (Hb)-related factors, and thus only indirectly measures anemia in patients. A recent study comparing various formulas for evaluating blood loss in total knee arthroplasties has shown that the Hb balance method, based on Hb measurements rather than hematocrit, is a more reliable method for estimating blood loss (Gao et al., 2015). While the Gross equation is commonly used among surgeons, the authors should consider using the Hb balance method in order to strengthen the validity of their results.
Blood loss associated with THA is a major concern for both patients and surgeons. Therefore, the study from Zhou et al. (2016) investigating the efficacy of different forms of TXA administration for reducing blood loss could prove valuable by providing surgeons with additional evidence for controlling this common complication. With additional considerations, we believe that the study by Zhou et al. (2016) may be effective in producing significant results identifying the relative efficacy of topical versus intravenous administration of TXA for preventing blood loss.
| References|| |
Danninger T, Memtsoudis SG (2015) Tranexamic acid and orthopedic surgery-the search for the holy grail of blood conservation. Ann Transl Med 3:77.
Emara WM, Moez KK, Elkhouly AH (2014) Topical versus intravenous tranexamic acid as a blood conservation intervention for reduction of post-operative bleeding in hemiarthroplasty. Anesth Essays Res 8:48-53.
Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H (2015) Four methods for calculating blood-loss after total knee arthroplasty. Chin Med J (Engl) 128:2856-2860.
Gillette BP, DeSimone LJ, Trousdale RT, Pagnano MW, Sierra RJ (2013) Low risk of thromboembolic complications with tranexamic acid after primary total hip and knee arthroplasty. Clin Orthop Relat Res 471:150-154.
Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Pérez-Chrzanowska H, Figueredo-Zalve R (2014) Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am 96:1937-1944.
Gross JB (1983) Estimating allowable blood loss: corrected for dilution. Anesthesiology 58:277-280.
North WT, Mehran N, Davis JJ, Silverton CD, Weir RM1, Laker MW (2016) Topical vs intravenous tranexamic acid in primary total hip arthroplasty: a double-blind, randomized controlled trial. J Arthroplasty 31:1022-1026.
Walker RW, Rosson JR, Bland JM (1997) Blood loss during primary total hip arthroplasty: use of preoperative measurements to predict the need for transfusion. Ann R Coll Surg Engl 79:438-440.
Wei W, Wei B (2014) Comparison of topical and intravenous tranexamic acid on blood loss and transfusion rates in total hip arthroplasty. J Arthroplasty 29:2113-2116
Zhou KD, Wang HY, Yan YF, Hong WX, Feng JM (2016) Clinical efficacy of tranexamic acid administration via different routes during total hip arthroplasty: study protocol for a prospective randomized controlled trial. Clin Transl Orthop 1:1-7.