Nancy A. Melville

May 13, 2015

Washington, DC — The intraoperative use of tranexamic acid (TXA) in craniofacial surgery for infants significantly reduces blood loss and the need for transfusions, a new study shows.

"We found that TXA improves blood loss during and after surgery," said first author Ruth E. Bristol, MD, from Barrow Neurological Institute at Phoenix Children's Hospital, Arizona.

"TXA allows for maintenance of higher hemoglobin or hematocrit (H/H) after surgery even without transfusion and it appears to be safe in the craniosynostosis population," she concluded.

The results were presented here at the American Association of Neurological Surgeons (AANS) 83rd Annual Meeting.

TXA is commonly used in various specialties for indications ranging from cardiac and orthopedic surgeries to dentistry, obstetrics, and hemophilia. However, its efficacy in open calvarial vault remodeling for craniosynostosis, which can involve extensive blood loss relative to infant size, remains uncertain.

For the study, Dr Bristol and her colleagues evaluated 81 patients with craniosynostosis who had anterior or posterior vault remodeling before the institution of a TXA administration protocol at the center and 36 patients who had the surgery after the implementation of a TXA protocol.

Under the protocol, patients received TXA, 10 mg/kg, at the start of surgery and 5 mg/kg per hour for 24 hours after surgery. Postoperative care otherwise remained the same after the implementation of the protocol.

The results showed that patients who received TXA in surgery had significantly less total blood transfusion during their surgery (258 mL) compared with the non-TXA group (390 mL; P = .009).

In addition, while patients who received TXA required no blood transfusions after surgery, those in the non-TXA group received an average of 78 mL postoperatively.

Patients receiving TXA had a lower estimated blood loss (260 mL) than did the non-TXA group (410 mL; P = .26).

TXA, a synthetic analogue of lysine, works by inhibiting activation of plasminogen to plasmin, slowing the degradation of fibrin, Dr Bristol explained.

She noted that a large review, published in Anaesthesiology Intensive Therapy looking at 100 trials and 10,000 patients showed the transfusion probability was reduced 38% with the use of TXA. Another paper published in Anesthesiology showed that the lack of TXA use in craniosynostosis was an indicator of postoperative events.

Important Evidence

Commenting on the study, discussant Mark R. Proctor, MD, an associated professor of neurosurgery at Boston Children's Hospital/Harvard Medical School, Massachusetts, agreed that the research adds important evidence of the potential benefits of TXA for use in craniosynostosis surgery.

"[The new study] further supports the use of TXA in children undergoing major craniofacial surgery," he said.

"TXA should be considered the standard of care. Future directions might include the topical use of TXA, as utilized in many orthopaedic procedures."

Dr Proctor was a coauthor on the Anesthesiology study on TXA use in craniosynostosis. Susan Goobie, MD, the lead author on that study, commented that several limitations in the new study should be considered, including its size.

"This study is a small, single-center retrospective study with small numbers," Dr Goobie, an assistant professor of anesthesia at Harvard Medical School and senior assistant in perioperative anesthesia at Children's Hospital in Boston, Massachusetts, told Medscape Medical News.

"They have shown that TXA is associated with a reduction of blood loss and blood transfusions, but honestly they have not shown that this independently is responsible for the result, as other factors such as the change in practice over time, i.e. better surgical technique and improved anesthetic management, including using blood conservation techniques, may also play a role."

In an earlier double-blind, placebo-controlled trial, Dr. Goobie and her colleagues showed that TXA significantly reduces blood loss by 55% and blood transfusion by 60% in open craniosynostosis surgical patients.

She noted that while the adverse effect profile is very low, there have been some isolated reports of postoperative seizures; however, those cases involved cardiac surgical patients getting 10 times the dose Dr Goobie typically uses.

"To be safe we recommend the lowest possible dose that is therapeutic," she said. "We recommended a low dose in our paper and our lab is actively studying this now."

Dr Goobie and her colleagues have authored a paper on antifibrinolytic safety that is under review, showing the incidence of reported adverse events in a large database to be less than 1%.

Dr Bristol, Dr Proctor, and Dr Goobie have disclosed no relevant financial relationships.

American Association of Neurological Surgeons (AANS) 83rd Annual Meeting. Abstract 819. Presented May 4, 2015.

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