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Efficacy of Tranexamic Acid in Pediatric Craniosynostosis Surgery: A Double-blind, Placebo-controlled Trial
Abstract
BACKGROUND: Extensive blood loss is common in pediatric craniosynostosis reconstruction surgery. Tranexamic acid (TXA) is increasingly used to reduce perioperative blood loss in various settings, but data on its efficacy are limited in children. The purpose of this randomized, double-blind, placebo-controlled, parallel trial was to evaluate the efficacy of TXA in pediatric craniosynostosis correction surgery. The primary and secondary outcome variables were reduction in perioperative blood loss and reduction in blood transfusion, respectively. METHODS: Forty-three children, ages 2 months to 6 yr, received either placebo or TXA in a loading dose of 50 mg·kg(-1), followed by an infusion of 5 mg·kg·h(-1) during surgery. TXA plasma concentrations were measured. RESULTS: The TXA group had significantly lower perioperative mean blood loss (65 vs. 119 ml·kg(-1), P < 0.001) and lower perioperative mean blood transfusion (33 vs. 56 ml· kg(-1), P = 0.006) compared to the placebo group. The mean difference between the TXA and placebo groups for total blood loss was 54 ml·kg(-1) (95% CI for the difference, 23-84 ml·kg(-1)) and for packed erythrocytes transfused was 23 ml·kg(-1) (95% CI for the difference, 7-39 ml·kg(-1)). TXA administration also significantly diminished (by two thirds) the perioperative exposure of patients to transfused blood (median, 1 unit vs. 3 units; P < 0.001). TXA plasma concentrations were maintained above the in vitro thresholds reported for inhibition of fibrinolysis (10 μg·ml(-1)) and plasmin-induced platelet activation (16 μg·ml(-1)) throughout the infusion. CONCLUSIONS: TXA is effective in reducing perioperative blood loss and transfusion requirement in children undergoing craniosynostosis reconstruction surgery.
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“They have the advantage of requiring fewer skin incisions and less blood loss and are therefore considered less invasive and more child-friendly [64,65,66,67,68,69,70].”
From Isolated Sagittal Craniosynostosis: A Comprehensive Review (2024) · cites this paper as [65]
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Afroze, F., Cyr, A. S., & Gorti, A. (2022) · Springer eBooks · doi:10.1007/978-981-19-0954-2_36
Craniosynostosis of the coronal suture. Case report and literature review
Portilla, L. I. V., Blum, M. F. F., Idrovo, M. V. L., Pérez, G. C. L., & García, M. A. L. (2022) · Salud Ciencia y Tecnología · doi:10.56294/saludcyt2022107
Zittel, S., Ristow, O., Moratin, J., Rückschloß, T., Hoffmann, J., Damaty, A. E., Freudlsperger, C., & Engel, M. (2023) · Journal of Craniofacial Surgery · doi:10.1097/scs.0000000000009282
What Drugs Decrease Perioperative Bleeding?
Andrawes, M. N. (2013) · Elsevier eBooks · doi:10.1016/b978-1-4557-2768-1.00024-5
Hematology and Coagulation Disorders
Guzzetta, N. A., & Miller, B. E. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-34125-7.00047-4
Soto, E., Johnston, J. M., Niedermeier, K., Braswell, A. C., Rozelle, C. J., Grant, J. H., & Myers, R. P. (2023) · FACE · doi:10.1177/27325016231206114
“9,23,24 It is notable that as in our findings neither of the RCTs noted a significant difference in their use of FFP, platelets or cryoprecipitate between the TXA and placebo groups.”
ResultNeurosurgical and craniofacial procedures
Hunter, S. A., & Stricker, P. A. (2023) · Elsevier eBooks · doi:10.1016/b978-0-323-90459-9.00011-6
Застосування антифібринолітичної терапії у періопераційному періоді у дітей та дорослих
Faryna, L., & Biliaiev, A. V. (2023) · Ukrainian Scientific Medical Youth Journal · doi:10.32345/usmyj.4(142).2023.137-144
“Схожий ефект від призначення ТКК от - римали у пацієнтів дитячого віку із краніоси - ностозом (King M. et al. 2022, Goobie S. et al. 2011).”
Tanova, R., Vasileva, P., Yankov, D., Ferdinandov, D., Georgiev, S., & Lilyanov, N. (2024) · Biotechnology & Biotechnological Equipment · doi:10.1080/13102818.2024.2338424
“Four randomized controlled trials [7,11,13,15] and three retrospective studies [6,9,10] have shown a significant reduction in the amount of transfused blood. our results are most similar to those of Fenger-eriksen et al. [7], who demonstrated a drop in the intraoperative red blood cell transfusions…”
Craniosynostosis: Anesthetic Considerations—What the Pediatric Neurosurgeon Should Know
Ekstein, M. P., Roth, J., & Constantini, S. (2024) · Springer eBooks · doi:10.1007/978-3-031-69386-1_29
Sagittal Suture Synostosis: Distraction Osteogenesis, Key Points for the Neurosurgeons
Shim, K., & Park, E.-K. (2024) · Springer eBooks · doi:10.1007/978-3-031-69386-1_40
Metadata
- Authors
- Goobie, S. M., Meier, P. M., Pereira, L. M., McGowan, F. X., Prescilla, R. P., Scharp, L. A., Rogers, G. F., Proctor, M. R., Meara, J. G., Soriano, S. G., Zurakowski, D., & Sethna, N. F.
- Affiliations
- Boston Children's Hospital (US)
- Instructor in Anesthesia.
- Massachusetts College of Pharmacy and Health Sciences (US)
- Professor of Anesthesia.
- Research Technician, †† Professor.
- Assistant Professor.
- Associate Professor, Department of Plastic and Oral Surgery.
- Assistant Professor of Anaesthesia (Director of Biostatistics).
- Associate Professor of Anesthesia, Department of Anesthesia, Perioperative, and Pain Medicine.
- ORCID
- Venue
- Anesthesiology
- Published
- 2011-04-01
- Volume
- 114
- Issue
- 4
- Pages
- 862-871
- ISSN
- 0003-3022 (ISSN-L)
- OpenAlex
- W2016016217
- Cited by
- 313
- References
- 46
- Citations by year
- 2026: 10 · 2025: 13 · 2024: 21 · 2023: 16 · 2022: 22 · 2021: 25 · 2020: 20 · 2019: 26 · 2018: 20 · 2017: 17 · 2016: 19 · 2015: 30 · 2014: 28 · 2013: 17 · 2012: 21
- FWCI
- 15.44
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Anesthesiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Hematology › Blood transfusion and management
- Health Sciences › Medicine › Surgery › Craniofacial Disorders and Treatments
- Health Sciences › Medicine › Hematology › Hemostasis and retained surgical items
- Keywords
- tranexamic acid, pediatric craniosynostosis, perioperative blood loss, blood transfusion, fibrinolysis inhibition, plasma drug concentration, children
- MeSH terms
- Antifibrinolytic Agents, Blood Transfusion, Child, Child, Preschool, Craniosynostoses, Double-Blind Method, Female, Humans, Infant, Intraoperative Care, Male, Tranexamic Acid, Blood Loss, Surgical, Treatment Outcome
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