A prospective randomized trial of patients enrolled at a university affiliated tertiary medical center between February and December 2017.
To compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with intravenous (IV) versus oral (PO) tranexamic acid (TXA).
The use of antifibrinolytic agents such as TXA to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. While evidence supports the use of IV and topical formulations of TXA in spine surgery, the use of PO TXA has not been studied.
Eighty-three patients undergoing thoracolumbar fusion were randomized to receive 1.95 g of PO TXA 2 hours preoperatively or 2 g IV TXA (1 g before incision and 1 g before wound closure) intraoperatively. The sample was further stratified into three categories based on number of levels fused (1–2 level fusions, 3–5, and >5). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test (TOST). A P-value of <0.05 suggested equivalence between treatments.
Fourty three patients received IV TXA and 40 patients received PO TXA. Patient demographic factors were similar between groups except for body mass index (BMI). The mean reduction of hemoglobin was similar between IV and PO groups (3.36 g/dL vs. 3.43 g/dL, respectively; P = 0.01, equivalence). Similarly, the calculated blood loss was equivalent (1235 mL vs. 1312 mL, respectively; P = 0.02, equivalence). Eight patients (19%) in IV TXA group received a transfusion compared with five patients in PO TXA group (13%) (P = 0.44). One patient (2% and 3% in IV and PO, respectively) in each group experienced a deep venous thrombosis/pulmonary embolism (P = 0.96).
Patients treated with IV and PO TXA experienced the same perioperative blood loss after spinal fusions. Given its lower cost, PO TXA represents an excellent alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve healthcare cost-efficiency in the studied population.
Level of Evidence: 1
Tranexamic acid (TXA) is widely utilized to decrease operative blood loss and allogenic blood transfusions. This prospective randomized trial compares perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with intravenous (IV) versus oral (PO) TXA. Not only is it cheaper, PO TXA was equivalent to IV TXA in reducing blood loss after spinal fusions.
∗Department of Orthopaedic Surgery, Henry Ford Health System, Detroit, Michigan
†Department of Orthopaedic Surgery, University of Maryland, Baltimore, Maryland
‡Wayne State University School of Medicine, Detroit, Michigan.
Address correspondence and reprint requests to Charles C. Yu, MD, Department of Orthopaedic Surgery, Henry Ford Health System, 2799 West Grand Blvd, Detroit, MI 48202; E-mail: email@example.com
Received 27 July, 2018
Revised 14 October, 2018
Accepted 19 November, 2018
The manuscript submitted does not contain information about medical device(s)/drug(s).
No funds were received in support of this work.
Relevant financial activities outside the submitted work: grants.