Mount Sinai study finds that blood clotting drug commonly used for orthopedic surgeries does not increase complications for high-risk patients

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Paper Title: Safety of Tranexamic Acid in Hip and Knee Arthroplasty in High-risk Patients

Journal: Anesthesiology

Authors: Jashvant Poeran MD, PhD, Director of the Center for Clinical and Outcomes Research, and Associate Professor of Population Health Science & Policy and Orthopedics at the Icahn School of Medicine at Mount Sinai; Calin S. Moucha, MD, Chief of Adult Reconstruction & Joint Replacement Surgery at Mount Sinai Hospital, and Associate Professor of Orthopedics at the Icahn School of Medicine at Mount Sinai; and other coauthors.

Bottom Line: The use of the drug tranexamic acid is commonplace in patients undergoing hip or knee replacement surgery to reduce blood loss. However, this drug works by promoting clotting and safety concerns exist when used in certain high-risk patients such as those with a history of heart attacks, seizures, blood clots, strokes/mini strokes, renal disease, or irregular and rapid heart rates.

Results: Using national data from more than 40,000 patients at 500 hospitals in this retrospective cohort study, Mount Sinai researchers found that approximately half of high-risk patients receive tranexamic acid, similar to non-high-risk patients. Moreover, tranexamic acid use in high-risk patients undergoing hip or knee replacement surgeries is associated with fewer blood transfusions. Most importantly, the researchers found that use of tranexamic acid is not associated with complications such as deep vein blood clots, heart attacks, seizures, or strokes/mini strokes when used in high-risk patients.

Why the Research Is Interesting: The findings address an important knowledge gap on the use of tranexamic acid, a drug that is currently used in the majority of patients undergoing hip and knee replacement surgery. It is unclear how safe this drug is when used in high-risk patients undergoing hip and knee replacement surgery. Mount Sinai’s research confirms prior smaller studies that show there is no evidence suggesting the drug carries more complications in high-risk patients.

However, the Mount Sinai team asserts the importance of continued studies to track the safety of tranexamic acid since it has become increasingly used in patients undergoing hip and knee replacement surgeries. Future studies should focus on more detailed parameters on how to reduce the risk of complications in high-risk patients, such as comparing different ways of administering the drug (oral, intravenous, or topical) and dose adjustments.

Who: More than 40,000 patients at 500 U. S. hospitals who underwent hip and knee replacement surgeries.

When: Orthopedic surgeries between 2013 to 2016.

What: The study measured the number of patients who experienced complications following administration of the clotting drug tranexamic acid during hip and knee replacement surgeries.

How: Using the national Premier Healthcare claims database, Mount Sinai researchers analyzed data on patients with preexisting comorbidities who underwent hip and replacement surgeries with use of tranexamic acid. They also considered patient outcomes including a new-onset complication, need for a blood transfusion, and hospital readmission.

Study Conclusions: Tranexamic acid, a decades-old clotting drug that is on the World Health Organization’s Essential Medicines list, has been used successfully in various scenarios, including hip and knee replacement surgery, to reduce blood loss and diminish the need for blood transfusions. However, concerns for potential complications persist, especially when the clotting drug is used in high-risk patients. The study did not show an increased risk for complications, and supplements previous smaller studies that confirm the safety of the drug when used in patients undergoing orthopedic surgery.

Said Mount Sinai’s Dr. Jashvant Poeran of the research:
This is by no means the final ‘say’ on this topic, but yet another encouraging sign of the safety of this drug. With an aging population, the demand for such orthopedic surgeries is going to increase and it is, therefore, important to continue study ways to improve patient care and outcomes.

Said Mount Sinai’s Dr. Calin S. Moucha of the research:
This is an important clinical conundrum that keeps on coming up as we are aware of the effectiveness of tranexamic acid, but there is not that much data out there on the safety of using tranexamic acid in high-risk patients. Our results will help anesthesiologists and surgeons in their clinical decision-making on something that is unlikely to be answered by a clinical trial.

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View the full paper here. To request a PDF of the paper or to schedule an interview with Dr. Poeran or Dr. Moucha, please contact the Mount Sinai Press Office at [email protected] or 347-346-3390.

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Stacy A. Anderson
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