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Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery

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Abstract

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.

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Funding

Direct support was received from AO Spine North America.

Author information

Authors and Affiliations

  1. Department of Orthopedic Surgery, Washington University School of Medicine, St. Louis, MO, USA

    John C. F. Clohisy & Elfaridah Frazier

  2. Department of Orthopedic Surgery, Columbia University Medical Center, New York, NY, USA

    Lawrence G. Lenke

  3. Department of Orthopedic Surgery, University of Chicago, Chicago, IL, USA

    Mostafa H. El Dafrawy

  4. Perioperative Services and Surgical Critical Care, Barnes-Jewish Hospital, St. Louis, MO, USA

    Rachel C. Wolfe

  5. Rady Children’s Hospital, University of California, 3020 Children’s Way, San Diego, CA, 92123, USA

    Michael P. Kelly

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  1. John C. F. Clohisy
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  2. Lawrence G. Lenke
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  3. Mostafa H. El Dafrawy
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  4. Rachel C. Wolfe
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  5. Elfaridah Frazier
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Contributions

JCC: analyzed data, drafted initial manuscript, approved final manuscript, interpretation; MHD, RCW, EF: assisted with data collection, data analysis and interpretation, approved final manuscript; LGL: design, acquisition of data, conceived initial study, assisted with data collection, approved final manuscript; MPK: conceived initial study, collected and analyzed data, critically revised manuscript, approved final manuscript, drafting, interpretation.

Corresponding author

Correspondence to Michael P. Kelly.

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Conflict of interest

Drs. Clohisy, El Dafrawy, Frazier, and Ms. Wolfe report no conflicts of interest. Dr. Kelly reports research funding support to his institution paid by the Setting Scoliosis Straight Foundation. Dr. Lenke reports being a consultant for Medtronic (money donated to charity); receiving royalties from Medtronic and Quality Medical Publishing; receiving reimbursement for airfare and hotels from Broadwater, the Seattle Science Foundation, Stryker Spine, the Spinal Research Foundation, AOSpine, and the Scoliosis Research Society; receiving grant support from the Scoliosis Research Society (money to his institution), EOS Imaging (money to his institution), the Setting Scoliosis Straight Foundation (money to his institution); and receiving grant and fellowship support from AOSpine (money to his institution).

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Washington University IRB # 201312010.

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Clohisy, J.C.F., Lenke, L.G., Dafrawy, M.H.E. et al. Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery. Spine Deform 10, 1399–1406 (2022). https://doi.org/10.1007/s43390-022-00539-z

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