Oral Is as Effective as Intravenous Tranexamic Acid at Reducing Blood Loss in Thoracolumbar Spinal Fusions: A Prospective Randomized Trial.
Journal
Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646
Informations de publication
Date de publication:
15 Jan 2022
15 Jan 2022
Historique:
pubmed:
6
7
2021
medline:
15
12
2021
entrez:
5
7
2021
Statut:
ppublish
Résumé
A prospective randomized trial at a university affiliated tertiary medical center between February 2017 and March 2020. The aim of this study was to compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with IV versus PO TXA. The use of antifibrinolytic agents such as tranexamic acid (TXA) to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. Although evidence supports the use of intravenous (IV) and topical formulations of TXA in spine surgery, the use of oral (PO) TXA has not been studied. A total of 261 patients undergoing thoracolumbar fusion were randomized to receive 1.95 g of PO TXA 2 hours preoperatively or 2 g IV TXA (1 g before incision and 1 g before wound closure) intraoperatively. The sample was further stratified into three categories based on number of levels fused (one-to two-level fusions, three to five, and more than five). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test. One hundred thirty-seven patients received IV and 124 received PO TXA. The average age was 62 ± 13 years (mean ± SD), including 141 females and 120 males. Revision cases comprised of 67% of the total sample. Patient demographic factors were similar between groups except for weight, BMI, and preoperative platelet count. The mean reduction of hemoglobin was similar between IV and PO groups (3.56 vs. 3.28 g/dL, respectively; P = 0.002, equivalence). IV TXA group had a higher transfusion rate compared to PO TXA group (22 patients [19%] vs. 12 patients [10%]; P = 0.03). In addition, IV group had longer length of stay (LOS) than PO group (4.4 vs. 3.7 days; P = 0.02). Patients treated with IV and PO TXA experienced the same perioperative blood loss after small and large spinal fusions. In subgroup analysis, the intermediate (three to five level) spinal fusions had less blood loss with PO TXA than IV TXA. Given its lower cost, PO TXA represents a superior alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve health care cost-efficiency in the studied population.Level of Evidence: 1.
Sections du résumé
STUDY DESIGN
METHODS
A prospective randomized trial at a university affiliated tertiary medical center between February 2017 and March 2020.
OBJECTIVE
OBJECTIVE
The aim of this study was to compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with IV versus PO TXA.
SUMMARY OF BACKGROUND DATA
BACKGROUND
The use of antifibrinolytic agents such as tranexamic acid (TXA) to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. Although evidence supports the use of intravenous (IV) and topical formulations of TXA in spine surgery, the use of oral (PO) TXA has not been studied.
METHODS
METHODS
A total of 261 patients undergoing thoracolumbar fusion were randomized to receive 1.95 g of PO TXA 2 hours preoperatively or 2 g IV TXA (1 g before incision and 1 g before wound closure) intraoperatively. The sample was further stratified into three categories based on number of levels fused (one-to two-level fusions, three to five, and more than five). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test.
RESULTS
RESULTS
One hundred thirty-seven patients received IV and 124 received PO TXA. The average age was 62 ± 13 years (mean ± SD), including 141 females and 120 males. Revision cases comprised of 67% of the total sample. Patient demographic factors were similar between groups except for weight, BMI, and preoperative platelet count. The mean reduction of hemoglobin was similar between IV and PO groups (3.56 vs. 3.28 g/dL, respectively; P = 0.002, equivalence). IV TXA group had a higher transfusion rate compared to PO TXA group (22 patients [19%] vs. 12 patients [10%]; P = 0.03). In addition, IV group had longer length of stay (LOS) than PO group (4.4 vs. 3.7 days; P = 0.02).
CONCLUSION
CONCLUSIONS
Patients treated with IV and PO TXA experienced the same perioperative blood loss after small and large spinal fusions. In subgroup analysis, the intermediate (three to five level) spinal fusions had less blood loss with PO TXA than IV TXA. Given its lower cost, PO TXA represents a superior alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve health care cost-efficiency in the studied population.Level of Evidence: 1.
Identifiants
pubmed: 34224510
doi: 10.1097/BRS.0000000000004157
pii: 00007632-202201150-00001
doi:
Substances chimiques
Antifibrinolytic Agents
0
Tranexamic Acid
6T84R30KC1
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
91-98Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
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