Matthew A Halanski1, Jeffrey A Cassidy2, Scott Hetzel3, Diann Reischmann4, Nabil Hassan5. 1. Department of Orthopaedics and Rehabilitation, University of Wisconsin/American Family Children's Hospital, UMMF Centennial Building, 1685 Highland Avenue, Room 6170-12D, Madison, WI 53705-2281, USA. Electronic address: halanski@ortho.wisc.edu. 2. Department of Pediatric Orthopaedics, Helen DeVos Children's Hospital, 100 Michigan NE, Grand Rapids, MI 49503, USA. 3. Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, 4269A HSLC, 750 Highland Avenue, Madison, WI 53705, USA. 4. Department of Statistics, Grand Valley State University, A-1-178 Mackinac Hall, Allendale, MI 49401, USA. 5. Pediatric Critical Care Medicine and Pediatric Blood Management Program, Helen DeVos Children's Hospital, 100 Michigan NE, Grand Rapids, MI 49503, USA.
Abstract
STUDY DESIGN: Single-center, prospective, randomized, double-blinded trial. OBJECTIVES: To compare blood loss, allogenic transfusion requirements, and coagulation parameters between pediatric spinal deformity patients receivingaminocaproic acid (Amicar) or tranexamic acid (TXA) during posterior spinal fusion. SUMMARY OF BACKGROUND DATA: Amicar and TXA have been shown to decrease blood loss in pediatric spinal deformity cases compared with controls. The difference in efficacy between these medications in this population has not been reported. METHODS: Enrolled patients were randomized to receive either Amicar or TXA during scoliosis surgery. Baseline demographic and deformity comparisons were collected. Intraoperative comparisons included estimated and calculated blood loss, number of levels instrumented, number of osteotomies, operative time, and allogenic transfusion requirements. Preoperative and postoperative hemoglobin, platelets, prothrombin time, partial prothrombin time (PTT), international normalized ratio (INR), and fibrinogen were recorded. RESULTS: A total of 47 patients were enrolled with data available for review (N = 25, Amicar; N = 22, TXA). No difference in cohorts was found in demographics, preoperative hemoglobin, platelets, prothrombin time, PTT, INR, initial Cobb angle, average number of: levels fused, patients with osteotomies and osteotomies, operative time, and final Cobb angles. Estimated blood loss was significantly less (about 221 mL) than the calculated blood loss in both groups (p = .003). Estimated blood loss (1,088 vs. 726 mL; p = .055) and calculated blood loss (1,366 vs. 903 mL; p = .13) trended higher in the Amicar group. Although no difference in allogenic transfusion rates (20% vs. 14%) was observed, average volumes transfused were significantly higher in the Amicar cohort (1,014 vs. 461 mL; p = .03). The TXA cohort demonstrated a statistically significant smaller change in INR, a lower PTT, and greater fibrinogen levels postoperatively. CONCLUSIONS: Compared with Amicar, TXA use was associated with a lower allogenic transfusion requirement, less alteration in postoperative clotting studies, and a trend toward lower blood loss in pediatric posterior spinal fusion patients.
RCT Entities:
STUDY DESIGN: Single-center, prospective, randomized, double-blinded trial. OBJECTIVES: To compare blood loss, allogenic transfusion requirements, and coagulation parameters between pediatric spinal deformitypatients receiving aminocaproic acid (Amicar) or tranexamic acid (TXA) during posterior spinal fusion. SUMMARY OF BACKGROUND DATA: Amicar and TXA have been shown to decrease blood loss in pediatric spinal deformity cases compared with controls. The difference in efficacy between these medications in this population has not been reported. METHODS: Enrolled patients were randomized to receive either Amicar or TXA during scoliosis surgery. Baseline demographic and deformity comparisons were collected. Intraoperative comparisons included estimated and calculated blood loss, number of levels instrumented, number of osteotomies, operative time, and allogenic transfusion requirements. Preoperative and postoperative hemoglobin, platelets, prothrombin time, partial prothrombin time (PTT), international normalized ratio (INR), and fibrinogen were recorded. RESULTS: A total of 47 patients were enrolled with data available for review (N = 25, Amicar; N = 22, TXA). No difference in cohorts was found in demographics, preoperative hemoglobin, platelets, prothrombin time, PTT, INR, initial Cobb angle, average number of: levels fused, patients with osteotomies and osteotomies, operative time, and final Cobb angles. Estimated blood loss was significantly less (about 221 mL) than the calculated blood loss in both groups (p = .003). Estimated blood loss (1,088 vs. 726 mL; p = .055) and calculated blood loss (1,366 vs. 903 mL; p = .13) trended higher in the Amicar group. Although no difference in allogenic transfusion rates (20% vs. 14%) was observed, average volumes transfused were significantly higher in the Amicar cohort (1,014 vs. 461 mL; p = .03). The TXA cohort demonstrated a statistically significant smaller change in INR, a lower PTT, and greater fibrinogen levels postoperatively. CONCLUSIONS: Compared with Amicar, TXA use was associated with a lower allogenic transfusion requirement, less alteration in postoperative clotting studies, and a trend toward lower blood loss in pediatric posterior spinal fusion patients.