Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications

Signe Elmose*, Mikkel Ø Andersen, Else Bay Andresen, Leah Yacat Carreon

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

OBJECTIVEThe purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery-specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.METHODSThe authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.RESULTSOf the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.CONCLUSIONSTranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.Clinical trial registration no.: NCT03714360 (clinicaltrials.gov).

Original languageEnglish
JournalJournal of Neurosurgery: Spine
Volume31
Issue number2
Pages (from-to)194-200
ISSN1547-5654
DOIs
Publication statusPublished - Aug 2019

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Randomized Controlled Trials
Placebos
Hypersensitivity
Clinical Trials
Acids

Keywords

  • Blood loss
  • Decompression
  • Discectomy
  • Lumbar
  • Minor spinal surgery
  • Operative time
  • Tranexamic acid

Cite this

@article{06f68a7a14b64769a7e1561f8ff41f7d,
title = "Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications",
abstract = "OBJECTIVEThe purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery-specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.METHODSThe authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.RESULTSOf the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50{\%} vs placebo 32{\%}, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62{\%} significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.CONCLUSIONSTranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.Clinical trial registration no.: NCT03714360 (clinicaltrials.gov).",
keywords = "Blood loss, Decompression, Discectomy, Lumbar, Minor spinal surgery, Operative time, Tranexamic acid",
author = "Signe Elmose and Andersen, {Mikkel {\O}} and Andresen, {Else Bay} and Carreon, {Leah Yacat}",
year = "2019",
month = "8",
doi = "10.3171/2019.1.SPINE1814",
language = "English",
volume = "31",
pages = "194--200",
journal = "Journal of Neurosurgery: Spine",
issn = "1547-5654",
publisher = "American Association of Neurological Surgeons",
number = "2",

}

Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery : no effect on operative time, intraoperative blood loss, or complications. / Elmose, Signe; Andersen, Mikkel Ø; Andresen, Else Bay; Carreon, Leah Yacat.

In: Journal of Neurosurgery: Spine, Vol. 31, No. 2, 08.2019, p. 194-200.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery

T2 - no effect on operative time, intraoperative blood loss, or complications

AU - Elmose, Signe

AU - Andersen, Mikkel Ø

AU - Andresen, Else Bay

AU - Carreon, Leah Yacat

PY - 2019/8

Y1 - 2019/8

N2 - OBJECTIVEThe purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery-specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.METHODSThe authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.RESULTSOf the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.CONCLUSIONSTranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.Clinical trial registration no.: NCT03714360 (clinicaltrials.gov).

AB - OBJECTIVEThe purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery-specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.METHODSThe authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p < 0.05.RESULTSOf the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.CONCLUSIONSTranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.Clinical trial registration no.: NCT03714360 (clinicaltrials.gov).

KW - Blood loss

KW - Decompression

KW - Discectomy

KW - Lumbar

KW - Minor spinal surgery

KW - Operative time

KW - Tranexamic acid

U2 - 10.3171/2019.1.SPINE1814

DO - 10.3171/2019.1.SPINE1814

M3 - Journal article

C2 - 30978683

VL - 31

SP - 194

EP - 200

JO - Journal of Neurosurgery: Spine

JF - Journal of Neurosurgery: Spine

SN - 1547-5654

IS - 2

ER -