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Research ArticleOther and Special Categories

Efficacy and Safety Profile of Tranexamic Acid in Traumatic Thoracolumbar Fracture Management: A Systematic Review and Meta-Analysis

Srivatsan Thirumalai Vasu, Lakshay Raheja, Kanishk Parmar and Sudheesh Ramachandran
International Journal of Spine Surgery June 2022, 16 (3) 567-580; DOI: https://doi.org/10.14444/8257
Srivatsan Thirumalai Vasu
1 Department of Neurosurgery, Medical Trust Hospital, Kochi, Kerala, India
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Lakshay Raheja
1 Department of Neurosurgery, Medical Trust Hospital, Kochi, Kerala, India
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Kanishk Parmar
1 Department of Neurosurgery, Medical Trust Hospital, Kochi, Kerala, India
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Sudheesh Ramachandran
1 Department of Neurosurgery, Medical Trust Hospital, Kochi, Kerala, India
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    Figure 1

    PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram.

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    Figure 2

    Risk of bias table generated using the RoB-2 tool.

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    Figure 3

    Funnel plot of intraoperative blood loss demonstrating publication bias. SE, standard error; SMD, standard mean difference.

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    Figure 4

    Forest plot showing the effect of tranexamic acid on total blood loss.

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    Figure 5

    (A) Forest plot showing the effect of tranexamic acid (TXA) on intraoperative blood loss. (B) Forest plot showing the effect of TXA on intraoperative blood loss after leave-one-out analysis and exclusion of Weera 2018.

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    Figure 6

    Forest plot showing effect of tranexamic acid on postoperative blood loss.

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    Figure 7

    Forest plot showing effect of tranexamic acid on hidden blood loss.

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    Figure 8

    Forest plot showing effect of tranexamic acid on perioperative hemoglobin levels.

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    Figure 9

    (A) Forest plot showing effect of topical tranexamic acid (tTXA) on operative duration. (B) Forest plot showing effect of tTXA on operative duration after leave-one-out analysis and exclusion Jieliang 2020.

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    Figure 10

    (A) Forest plot showing effect of intravenous tranexamic acid (iTXA) on operative duration. (B) Forest plot showing effect of iTXA on operative duration after leave-one-out analysis and exclusion of Wentao 2018.

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    Figure 11

    Forest plot showing effect of tranexamic acid on blood transfusions.

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    Figure 12

    Forest plot showing effect of tranexamic acid on length of hospital stay.

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    Figure 13

    Forest plot showing effect of tranexamic acid on incidence of deep vein thrombosis.

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    Figure 14

    Forest plot showing effect of tranexamic acid on incidence of pulmonary embolism.

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    Table 1

    Studies included in the qualitative and quantitative synthesis.

    StudyCountryStudy TypeSurgical MethodGroupsAge, y, Mean ± SDGender M:FTXA DosingInclusion CriteriaExclusion CriteriaOutcome Measures
    Garg 201224 IndiaProspective, randomizedOpen posterior instrumentationIntervention, ControlNot mentionedNot mentioned15 mg/kg bolus IV, 15 min before incisionNot mentionedNot mentionedIBL, PBL, numberof blood transfusions, DVT incidence, and D-D
    Hamdi 201625 TunisiaProspective, randomizedNot mentionedIntervention, Control48.4 ± 16.2, 54.4 ± 13.717:8, 15:1010 mg/kg bolus IV, 1 mg/kg/h IV intra-and postoperativelyNot mentionedNot mentionedIBL, PBL, numberof blood transfusions, DVT incidence, and D-D
    Weera 201926 ThailandProspective, randomizedOpen long-segment PSF without decompressionIntervention, Control52 (33.5, 55.5), 51.5 (33.5, 58)20:9, 15:131 g in 20 mL saline topical application via drain, clamped for 2 hAdults with thoracolumbar fractures undergoing posterior fixation surgery, no neurological deficits, ASA I, II, IIIHistory of thromboembolic/cardiac disease, coagulation disorder displaced laminar fracturesTransfusion rates, PBL, drain removal time, duration of hospitalization
    Xiji 201927 ChinaProspective, randomized, single blindedPercutaneous pedicle screw fixationIntervention A, Intervention B, Intervention C45.43 ± 8.18, 45.72 ± 9.96, 45.47 ± 11.2434:27, 37:24, 33:26Group A: 15 mg/kg bolus IV, 30 min before incision, Group B: topical 3 g insaline before wound closure, Group C: combined IV+ topical as aboveAdults with single-level thoracolumbar fractures withno neurological deficits undergoingsurgery within 2wk of injuryHistory of DVT, intake of antiplatelet/anticoagulant medications, multiple injuriesPre- and postoperative: Hct, D-D; DVT inlower limbs, transfusionrate, complications, operative duration,IBL, TBL, HBL
    Wentao 201928 ChinaProspective, randomized, double blindedOpen PSF with transforaminal interbody fusionIntervention, Control41.2 ± 10.3, 42.5 ± 9.525:18, 18:1910 mg/kg bolus IV, 15 min before incision, 1 mg/kg/h infusion during surgeryAdult patients with fracture dislocation at the thoracolumbar junction undergoing surgery within 24 h for 2-level involvementInvolved segments above T11 or below L2, on anticoagulation, any contraindication to TXA use, severeinjuries, CSF leakageOperative duration, TBL, IBL, Hb, transfusionrate, DVT incidence, levels of pre- andpostoperative GMP 140, FIB, FDP, and D-D
    Feng 202029 ChinaRetrospective cohortPSF using Wiltse approachIntervention A, Intervention B, Control42.14 ± 9.86, 40.34 ± 10.28, 41.06 ± 10.2660:24, 57:30, 63:30Group A: 20 mg/kg TXA at 5 min before skin incision and 16 h after first dose; Group B received 20 mg/kg TXAat 5 min before skin incisionAdults with single segment fractures without neurological deficits who underwent surgery using the Wiltse approach and other conservatively managed fracturesPelvic and femoral fractures, cardiac/CNS disease, intake of medication that alter hemostasisPre- and postoperative: Hb, FDP, D-D, FIB, Hct, LFT, PT-INR, APTT, CRP, IL-6; DVT in lower limbs, transfusion rate, complications operative duration, IBL, TBL, HBL
    Pradhan 201530 NepalProspective, observationalOpen PSFIntervention, Control39.47 ± 13.52, 32.19 ± 10.71Notmentioned10 mg/kg bolus IV, 30 min before incision and 3 h postoperatively + oral medicationAdults undergoing single-level PSF2-Level surgeries, fracture level screw fixation, iliac crest graftPre- and postoperative Hb, PT-INR, transfusion rates, operative duration, IBL, PBL, complications
    Jieliang 202031 ChinaProspective, randomized, double blindedOpen PSFIntervention, Control38.85 ± 4.17, 39.41 ± 6.5125:14, 22:151 g in 100 mL saline topical application in the wound postmuscle dissection, kept for 5 minAdults with single-level thoracolumbar fractures with/without neurological deficits undergoing surgery within 24 hof injury without osteoporosisMultiple comorbidities, multiple fractures, coagulopathies, CSF leakage, pathological fracturesTBL, HBL, IBL, PBL, HB, Hct, transfusion rate, length of hospital stay, operative duration
    Abdel 202032 EgyptProspective, randomized, double blindedOpen PSFIntervention, Control52 (33.5, 55.5), 51.5 (33.5, 58)7:8, 4:111 g in 50 mL saline topical application via drain, clamped for 2 hAdults with thoracolumbar fractures without neurological deficitsRenal insufficiency, history of thromboembolism, history of cardiovascular diseases, coagulopathies, allergy to TXA, history of aspirin or NSAID intake 1 wk before randomizationPre- and postoperativeHb, PBL
    Lehman et al34 United StatesProspective, randomized, double blinded  3 g TXA in 70 mL saline topical solution left in wound for 5 min vs saline placebo Adult thoracolumbar spine trauma with/without deficits undergoing surgery within 21 d; adult patients undergoing long-segment fusions (>5 fusion levels)Coagulopathies or history of thromboembolic events; therapeutic anticoagulation requirement; use of intravenous TXA during prestudy period; trauma penetrating spinal cord or dural tears; history of seizure; traumatic brain injuryPrimary outcome: maximal postoperative Hb drop, secondry outcomes: Health related quality of life, complications, cost analysis, surgical site infection, systemic absorption
    Sheng et al33 ChinaRandomized controlled trial, single blinded  Group 1: intravenous TXA 10 mg/kg before incision; Group 2 topical TXA 10 mg/kg wash before wound closure; Group 3: saline placeboAdult thoracolumbar spine trauma with no coagulopathy undergoing surgery within 2 wkLow Hb or platelet counts or preoperative coagulopathy; has received antiplatelet/coagulant therapy; hypercoagulable states or history of thromboembolismPrimary outcome: IBL; secondary outcome: blood transfusion, PBL, Hb, PT-INR, D-D. and APTT
    • APTT, activated prothrombin time; CSF, cerebrospinal fluid; D-D, D-dimer; DVT, deep vein thrombosis; FDP, fibrinogrn degeneration products; FIB, fibrinogen intermediate products; Hb, hemoglobin; HBL, hidden blood loss; Hct, hematocrit; IBL, intraoperative blood loss; IV, intravenous; NSAID, non-steroidal anti-inflammatory drugs; PBL, postoperative blood loss; PE, pulmonary embolism; PSF, pedicle screw fixation; PT-INR, prothrombin time-international normalized ratio; TBL, total blood loss; TXA, tranexamic acid.

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    Table 2

    Nonrandomized studies evaluated for bias using the MINORS criteria.

    MINORS CriteriaPradhan 2015Feng 2020
    1Clearly stated aim22
    2Inclusion of consecutive patients00
    3Prospective collection of data20
    4Endpoints appropriate to aim of study22
    5Unbiased assessment of the study endpoint02
    6Follow-up period appropriate to the aim of the study11
    7Loss to follow-up less than 5%00
    8Prospective calculation of study size00
    9An adequate control group22
    10Contemporary groups22
    11Baseline equivelance of groups22
    12Adequate statistical analysis12
    Total1415
    • Note: The items are scored 0 (not reported), 1 (reported but inadequate) or 2 (reported and adequate). The global ideal score is 16 for non-comparative studies and 24 for comparative studies

    • MINORS, methodological index for nonrandomized studies.

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Efficacy and Safety Profile of Tranexamic Acid in Traumatic Thoracolumbar Fracture Management: A Systematic Review and Meta-Analysis
Srivatsan Thirumalai Vasu, Lakshay Raheja, Kanishk Parmar, Sudheesh Ramachandran
International Journal of Spine Surgery Jun 2022, 16 (3) 567-580; DOI: 10.14444/8257

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Efficacy and Safety Profile of Tranexamic Acid in Traumatic Thoracolumbar Fracture Management: A Systematic Review and Meta-Analysis
Srivatsan Thirumalai Vasu, Lakshay Raheja, Kanishk Parmar, Sudheesh Ramachandran
International Journal of Spine Surgery Jun 2022, 16 (3) 567-580; DOI: 10.14444/8257
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