Tranexamic acid appeared to decrease the need for blood transfusions without increasing the risk for thromboembolic events or renal failure in patients undergoing joint replacement surgery, a new study shows.
Jashvant Poeran, MD, PhD, from the Institute of Healthcare Delivery Science in the Mount Sinai Hospital System in New York City, and colleagues present the results of their retrospective cohort study in an article published online August 12 in the BMJ. The population-based study included 872,416 total hip and knee arthroplasty procedures. The investigators were able to control for individual-level factors as well as hospital clusters in multivariable analyses.
"Utilizing population based data we found that tranexamic acid was effective in reducing the need for blood transfusions while not increasing the risk of complications, including thromboembolic events and renal failure. Although our data provide incremental evidence of the potential effectiveness and safety of tranexamic acid in patients requiring orthopedic surgery, this study has limitations inherent to observational analyses," the authors write.
Their results are consistent with previous small, randomized controlled trials indicating that tranexamic acid was effective in reducing blood transfusions.
"When analyzing the impact of tranexamic acid use on complications we found no increased risk for adverse outcomes in general, and for thromboembolic events and acute renal failure in particular. In fact, the multilevel model showed significantly decreased risks for some complications. These complications have been put forward by several clinicians as major reasons for a conservative use of tranexamic acid given previously published concerns with agents of this category," they write.
The investigators note that their data were taken from an administrative database and that hemoglobin levels and other transfusion triggers were missing from the database.
The authors of an accompanying editorial were enthusiastic about the use of the tranexamic acid, although they called for a randomized control trial to validate the results of the current study.
"If tranexamic acid reduces rather than increases the risk of myocardial infarction in patients requiring surgery, it could be a highly cost effective way to improve surgical safety. The large reduction in the risk of myocardial infarction reported by Poeran and colleagues is consistent with this hypothesis. Although it would be premature to recommend the routine use of tranexamic acid in general and orthopaedic surgery, it is surely time to resolve this uncertainty in an adequately powered randomised controlled trial," write Katherine Ker, MSc, and Ian Roberts, MD, from the London School of Hygiene & Tropical Medicine in the United Kingdom.
Robert Molloy, MD, director of the Center for Adult Reconstruction in Orthopaedic Surgery, Cleveland Clinic, Ohio, was not affiliated with the research but commented on it for Medscape Medical News.
"The authors should be commended for their research on such a large population of patients. While the reduction in blood utilization is not surprising, this article further substantiates the efficacy and safety profile of TXA [tranexamic acid] in the total joint population. I believe that the use of TXA should be the standard of care for patients undergoing total joint arthroplasty, possibly utilizing topical TXA in higher-risk patients, and that further study is warranted to validate its safety in the high risk patient population."
Three coauthors were partly funded by the Clinical Translational Science Center; another coauthor was funded by the Anna Maria and Stephen Kellen Career development award. The other authors have disclosed no relevant financial relationships. Dr. Roberts and Ker are investigators on several randomized controlled trials of tranexamic acid in bleeding patients and have grant applications pending for trials of tranexamic acid in head injury and elective surgery although not orthopaedic surgery. Dr. Malloy has disclosed no relevant financial relationships.
BMJ. Published online August 12, 2014. Article full text, Editorial full text
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Cite this: Tranexamic Acid May Improve Orthopedic Surgery Outcomes - Medscape - Aug 15, 2014.