Study Design. Retrospective, observational study.
Objective. To compare the safety and efficacy of 2 pharmaceutical antifibrinolytic agents, aprotinin and tranexamic acid, in controlling blood loss during lumbar pedicle subtraction osteotomy (PSO) in adults.
Summary of Background Data. Reconstructive spinal surgeries, in particular lumbar PSOs, have been associated with large blood losses despite interventions (intraoperative blood salvaging, controlled hypotensive anesthesia). Since the 1990s, intraoperative administration of antifibrinolytics (aprotinin, tranexamic acid, e-aminocaproic acid) has gained popularity. This study assesses the safety and efficacy of 2 antifibrinolytics, aprotinin and tranexamic acid, during adult lumbar PSO procedures at one institution.
Methods. A retrospective comparative analysis of 44 consecutive adults undergoing posterior spinal fusion procedures with lumbar PSO at one institution was performed. Patients were analyzed according to treatment group: controls (10), aprotinin (14), and tranexamic acid (20). There were no significant differences in demographic (gender, age, comorbidities) or surgical traits (length of surgery, levels fused/exposed, preoperative hematocrit, bone graft source, primary/revision) between the 3 groups.
Results. The aprotinin group had significantly less intraoperative blood loss (1114 ± 992 mL; P < 0.01) than the tranexamic acid and control group (2102 ± 1076 mL and 2260 ± 1580 mL, respectively). The aprotinin group received significantly less blood (577 ± 806 mL; P < 0.002) during the surgical procedure than the tranexamic acid (1838 ± 1096 mL) and the control group (1502 ± 1241 mL). There were no major intraoperative complications for any of the treatment groups. There were no postoperative cases of seizures, MI, CVA, DVT, or PE with any of the treatment groups. There was one acute tubular necrosis event in the aprotinin group, which resolved before discharge but did required several days of dialysis.
Conclusion. The aprotinin treatment group lost significantly less blood and received significantly fewer blood transfusions than both the tranexamic acid and control groups without significant differences in intra- and postoperative complications. These results may justify further study of aprotinin and other antifibrinolytics for this specific indication (3-column lumbar osteotomies in the adult spinal deformity population). A multicenter randomized comparative analysis would be ideal.
We analyzed blood losses and transfusion requirements in adults undergoing posterior spinal fusions with lumbar pedicle subtraction osteotomy in 3 treatment groups aprotinin, tranexamic acid, and controls. The aprotinin group experienced significantly less blood losses and fewer transfusions. While there were no significant differences in intra- and postoperative complications, there was one case of ATN in the aprotinin group, which did resolve.
From the *Department of Orthopedics, Washington University, St. Louis, MO; and †Active Joints Orthopedics, Englewood, NJ.
Acknowledgment date: March 13, 2009. First revision date: May 4, 2009. Second revision date: May 20, 2009. Acceptance date: May 27, 2009.
Tranexamic acid is FDA approved for this indication and commercially available in United States. Aprotinin is FDA approved for this indication but no longer commercially available in the United States.
Corporate /Industry (Medtronic) funds were received in support of this work. One or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies.
None of the authors of this paper has any relationship whatsoever with the manufacturers of tranexamic acid or aprotinin.
Institutional Board Approval was obtained for this study from Washington University.
Address correspondence and reprint requests to Christine Baldus, RN, MHS, Washington University, Suite 11300, Campus Box 8233, St. Louis, MO 63110; E-mail: email@example.com