February 01, 2014
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Similar rates of blood loss found with popular antifibrinolytics for spine surgery
NEW ORLEANS — Results of a level 1 study showed that the use of tranexamic acid and epsilon-aminocaproic acid leads to a comparable reduction in intraoperative blood loss for spine deformity surgery patients aged older than 50 years.
“Tranexamic acid and epsilon-aminocaproic acid reduce surgical blood loss in patients older than 50 years when compared to controls, and both drugs have similar efficacy,” Thomas Cheriyan, MD, said in a presentation at the North American Spine Society Annual Meeting. “We have not made any definite conclusions on patients younger than 50 years, as the sample size was not large.”
Level 1 study
The principal investigator Thomas J. Errico, MD, professor of orthopedic and neurosurgery at NYU Langone Medical Center in New York designed a prospective, randomized, double-blinded controlled study of 52 adults with spine deformity who underwent posterior fusions of at least five levels. Nineteen patients received 10 mg/kg loading doses of tranexamic acid (TXA) followed by 1 mg/kg per hour maintenance doses; 19 patients received 100 mg/kg loading doses followed by 10 mg/kg per hour maintenance doses of epsilon-aminocaproic acid (EACA) and 14 patients received saline.
“The dose we used for epsilon-aminocaproic acid was 10 times that of tranexamic acid because tranexamic acid has shown to be 10 times more potent than epsilon-aminocaproic acid,” Cheriyan said.
Effect of age differences
The patients’ ages varied significantly between the groups with a mean age of 60 years in the TXA group, 47 years in the EACA group and 45 years in the placebo group; therefore, the researchers stratified the groups by patients younger than 50 years old (20 patients) and those patients who were 50 years old and older (32 patients).
Although older patients in the TXA and EACA groups had significantly less blood loss than the placebo group, the researchers found no significant differences between the three groups among patients aged younger than 50 years.
“A meaningful interpretation on transfusion rates was limited by the sample size in each group and, in the future, increasing the sample size is needed,” Cheriyan said.
The EACA and TXA groups each had one patient with a pulmonary embolism.
“Further extending the study with a dose-response comparison of tranexamic acid and aminocaproic acid would be useful,” according to Errico. – by Renee Blisard Buddle
Reference:
Cheriyan T. Paper #1. Presented at: North American Spine Society Annual Meeting; Oct. 9-12, 2013; New Orleans.
For more information:
Thomas Cheriyan, MD, can be reached at NYU Hospital for Joint Diseases, 301 E. 17th St., #1402, New York, NY 10003; email:
thomascheriyan@gmail.com.
Thomas J. Errico, MD, can be reached at NYU Langone Medical Center, Center for Musculoskeletal Care, 333 E. 38th St., New York, NY, 10016; email:
hjdspine@nyumc.org.
Disclosures: Cheriyan and Errico have no relevant financial disclosures.
Perspective
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Dean Chou, MD
Previous studies have shown that such agents as tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA) reduce blood loss, which is especially useful in large-volume blood loss in adult deformity surgery. What is interesting about this study is there did not appear to be a difference between TXA and EACA and neither medication made a difference in patients under age 50. There were pulmonary emboli seen in the treatment groups, but none in the placebo group, which is consistent with the pro-coagulative effects of these drugs. Thus, this study helps give us a clearer range of when to use either TXA or EACA in adult deformity surgery — patients aged older than 50 years without significant risk factors without deep venous thrombosis (DVT)) — and when not to — patients aged younger than 50 years or with high risk factors for DVT. Studying greater numbers of patients will eventually further elucidate the best utility of these drugs and define in whom they should not be used because of the risks.
Dean Chou, MD
Associate Professor of Neurosurgery
University of California San Francisco
San Francisco
Disclosures: Chou is a consultant to Globus, Medtronic, Orthofix and Depuy Synthes.
Perspective
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Kai-Ming Fu, MD, PhD
Adult spinal deformity is a disease that can result in significant pain and disability. Treatments for adult spinal deformity range from pain medications to corrective surgery. Multiple studies have shown that corrective surgery can result in dramatic reductions in pain and disability, while nonoperative interventions generally result in maintenance of symptom severity at best. This improvement from surgery is not without cost, as there can be significant morbidity associated with adult deformity surgery. Decreasing complications in adult spinal deformity surgery may lead to improved outcomes and will likely increase the number of patients considered candidates for surgery.
The present study is the first randomized control study to evaluate antifibrinolytics in adult spinal deformity surgery. It compared tranexamic acid, aminocaproic acid (EACA) and placebo in regard to effect on intraoperative and total blood loss as well as transfusion rates.
In patients older than age 50 years, those in the treatment arms had significantly less total blood loss. Also, those in the EACA treatment arm were transfused at third the rate of the placebo arm. Of note, thromboembolic events were few with one occurring in each treatment group.
Adult deformity surgery can result in significant improvement to a patient’s health and overall wellbeing. Investigations, such as this study, offer insight into decreasing the morbidity associated with these treatments.
Kai-Ming Fu, MD, PhD
Assistant Professor of Neurosurgery
Weill Cornell Medical College
New York City
Disclosures: Fu receives honoraria from DePuy Synthes and Medtronic.