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Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery.
Spine Deformity 2022 June 26
BACKGROUND: Tranexamic acid (TXA) is an anti-fibrinolytic effective in reducing blood loss in orthopedic surgery. The appropriate dosing protocol for adult spinal deformity (ASD) surgery is not known. The purpose of this study was to evaluate two TXA protocols [low dose (L): 10 mg/kg bolus, 1 mg/kg/hr infusion; high dose (H): 50 mg/kg, 5 mg/kg/hr] in complex ASD surgery.
METHODS: Inclusion criteria were ASD reconstructions with minimum 10 fusion levels or planned 3-column osteotomy (3CO). Standard demographic and surgical data were collected. Intraoperative estimated blood loss (EBL) was calculated by suction canisters minus irrigation plus estimated blood lost in sponges, estimated to the nearest 50 mL. Serious adverse events (SAE) were defined a priori as: venothromboembolic event (VTE), cardiac arrhythmia, myocardial infarction, renal dysfunction, and seizure. All SAE were recorded. Simple t tests compared EBL between groups. Mean EBL by total blood volume (TBV), transfusion volume, complications related to TXA were secondary outcomes.
RESULTS: Sixty-two patients were enrolled and 52 patients completed the study; 25 were randomized to H and 27 to L. Demographic and surgical variables were not different between the two groups. EBL was not different between groups (H: 1596 ± 933 cc, L: 2046 ± 1105 cc, p = 0.12, 95% CI: - 1022 to 122 cc). EBL as a percentage of TBV was lower for the high-dose group (H: 29.5 ± 14.8%, L: 42.5 ± 26.2%, p = 0.03). Intraoperative transfusion volume (H: 961 ± 505 cc, L: 1105 ± 808 cc, p = 0.5) and post-operative transfusion volume (H: 513 ± 305 cc, L: 524 ± 245 cc, p = 0.9) were not different. SAE related to TXA were not different (p = 0.7) and occurred in 2 (8%) H and 3 (11%) L. There was one seizure (H), 2 VTE, and 2 arrhythmias.
CONCLUSION: No differences in EBL, transfusion volume, nor SAE were observed between H and L dose TXA protocols. High dose was associated with decreased TBV loss (13%). Further prospective study, with pharmacologic analysis, is required to determine appropriate TXA dosage in ASD surgeries.
LEVEL OF EVIDENCE: Therapeutic Level II.
TRIAL REGISTRATION: The study was registered at Clinicaltrials.gov (NCT02053363) February 3, 2014.
METHODS: Inclusion criteria were ASD reconstructions with minimum 10 fusion levels or planned 3-column osteotomy (3CO). Standard demographic and surgical data were collected. Intraoperative estimated blood loss (EBL) was calculated by suction canisters minus irrigation plus estimated blood lost in sponges, estimated to the nearest 50 mL. Serious adverse events (SAE) were defined a priori as: venothromboembolic event (VTE), cardiac arrhythmia, myocardial infarction, renal dysfunction, and seizure. All SAE were recorded. Simple t tests compared EBL between groups. Mean EBL by total blood volume (TBV), transfusion volume, complications related to TXA were secondary outcomes.
RESULTS: Sixty-two patients were enrolled and 52 patients completed the study; 25 were randomized to H and 27 to L. Demographic and surgical variables were not different between the two groups. EBL was not different between groups (H: 1596 ± 933 cc, L: 2046 ± 1105 cc, p = 0.12, 95% CI: - 1022 to 122 cc). EBL as a percentage of TBV was lower for the high-dose group (H: 29.5 ± 14.8%, L: 42.5 ± 26.2%, p = 0.03). Intraoperative transfusion volume (H: 961 ± 505 cc, L: 1105 ± 808 cc, p = 0.5) and post-operative transfusion volume (H: 513 ± 305 cc, L: 524 ± 245 cc, p = 0.9) were not different. SAE related to TXA were not different (p = 0.7) and occurred in 2 (8%) H and 3 (11%) L. There was one seizure (H), 2 VTE, and 2 arrhythmias.
CONCLUSION: No differences in EBL, transfusion volume, nor SAE were observed between H and L dose TXA protocols. High dose was associated with decreased TBV loss (13%). Further prospective study, with pharmacologic analysis, is required to determine appropriate TXA dosage in ASD surgeries.
LEVEL OF EVIDENCE: Therapeutic Level II.
TRIAL REGISTRATION: The study was registered at Clinicaltrials.gov (NCT02053363) February 3, 2014.
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