Tranexamic acid has no advantage in head and neck surgical procedures: a randomised, double-blind, controlled clinical trial

Thakur, Ashwani Kumar; Gupta, Sanjay; Thakur, Jagdeep S; Minhas, R. S.; Azad, Ramesh K.; Vasanthalakshmi, M S; Sharma, Dev; Mohindroo, NK

doi:10.1017/s0022215119002305

Cited by 8 publications

(13 citation statements)

References 13 publications

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“…investigate the effect of tranexamic acid (compared to saline placebo) on post-operative blood loss in various head and neck surgical procedures (including thyroid and parotid surgery, and neck dissections, with or without primary tumour excision) in a double-blinded, randomised, controlled trial involving 92 patients. 4 Although this prospective, randomised, placebo-controlled clinical trial found a reduction in post-operative drain volume in the tranexamic acid group, the difference was not statistically significant between the various head and neck surgical procedure groups. Despite confirming the null hypothesis, this is a useful study that supports previously published data in this patient group and confirms there does not appear to be a significant benefit of the use of tranexamic acid in this group of patients.…”

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confidence: 69%

Tranexamic acid in ENT

Fishman¹,

Hussain²,

Fisher³

2019

J. Laryngol. Otol.

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Interest in tranexamic acid has re-emerged with the recent publication of the CRASH-3 study. 1 This landmark study involving 12 737 patients demonstrated that tranexamic acid is safe in patients with traumatic brain injury, and treatment within 3 hours of injury reduces head injury related death. Within the field of ENT, tranexamic acid has primarily been studied in the management of tonsillectomy bleeding, epistaxis and functional endoscopic sinus surgery. 2,3 In this month's issue of The Journal of Laryngology & Otology, two articles investigate whether there is a role for tranexamic acid in other settings, thereby potentially extending its applications within ENT. Thakur et al. investigate the effect of tranexamic acid (compared to saline placebo) on post-operative blood loss in various head and neck surgical procedures (including thyroid and parotid surgery, and neck dissections, with or without primary tumour excision) in a double-blinded, randomised, controlled trial involving 92 patients. 4 Although this prospective, randomised, placebo-controlled clinical trial found a reduction in post-operative drain volume in the tranexamic acid group, the difference was not statistically significant between the various head and neck surgical procedure groups. Despite confirming the null hypothesis, this is a useful study that supports previously published data in this patient group and confirms there does not appear to be a significant benefit of the use of tranexamic acid in this group of patients. 5 Also in this month's issue, Das et al. assess whether tranexamic acid improves intra-operative visualisation in endoscopic ear surgery. 6 This randomised, controlled (comparing tranexamic acid to saline placebo) and double-blinded study found that tranexamic acid appears to be an effective haemostat in endoscopic ear surgery, thus improving surgical field visualisation, especially during manipulation of the external auditory canal soft tissues. With respect to the middle ear, no statistically significant difference was found between the two agents.

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confidence: 69%

Tranexamic acid in ENT

Fishman¹,

Hussain²,

Fisher³

2019

J. Laryngol. Otol.

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“…According to the results, there was no statistically significant relationship between the control and experimental groups of Group 1 and Group 2 regarding BL during and after surgery, which was consistent with the results of the present study in terms of BL after surgery but inconsistent with the present results in terms of BL during surgery. [12]…”

Section: Discussionmentioning

confidence: 99%

Can Tranexamic Acid Control Bleeding during and After Total Thyroidectomy? A Randomized Double-blind Clinical Trial Study

Alipour¹,

Jafari²,

Dashti³

et al. 2020

Clin J Surg

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Introduction: Head and neck operations are among the thyroid surgeries which are occasionally accompanied by blood loss (BL) during operation, tainting the operating field, and increasing the probability of damage to adjacent structures. Several studies have hitherto been conducted toward decreasing the BL that occurs during and after the operation. This study has been designed and executed with the objective of determining and comparing the effectiveness of tranexamic acid (TA) medication on controlling BL during and after total thyroidectomy. Materials and Methods: This study was carried out as a double-blind clinical trial on 83 patients affected with benign and malignant pathologies which were candidates for total thyroidectomy surgical operation, referred to the surgery department of Shahid Rahnemoun Hospital in Yazd, Iran, during a 1-year period. Patients were randomly divided into two groups including TA recipients, for which 20 mg/kg of TA was diluted to 20 cc with normal saline before surgery, and the control group which did not receive TA. The amount of BL during surgery was measured based on the blood gas value at the time of operation and post-surgery BL was measured based on the amount of blood collected in the Hemovac drain. The patients' hemoglobin was also measured and recorded before surgery and 24 h after surgery. Results: Among the 83 studied patients, 42 patients received TA, whereas the other 41 did not receive this medication. BL during surgery in the TA receiving group was significantly less than the control group (P = 0.016). Post-operation BL in the TA receiving group was also less than the control group, although the difference was not statistically significant (P = 0.5). Moreover, the decline of hemoglobin level 24 h after surgery was not significant in the TA receiving group and the control group. Conclusion: According to the results of the present study, TA significantly reduces the amount of BL during the surgical procedure of total thyroidectomy. TA also results in a non-significant reduction of post-operation BL, whereas the hemoglobin level is not affected by it.

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“…do not differ significantly with the use of TXA and continue to present as a major challenge. into two main categories-8 out of the 16 studies were identified to be major H&N surgical studies [6][7][8][18][19][20][21][22] while the other 8 were tonsillectomy studies. [23][24][25][26][27][28][29][30] The characteristics of the studies for the tonsillectomy studies are defined in Table 4 and for the H&N studies in Table 5, including a breakdown of the type of H&N operations undertaken.…”

Section: The Rates Of Secondary Posttonsillectomy Haemorrhagementioning

confidence: 99%

“…The use of TXA in H&N surgery has been investigated by multiple randomised controlled trials (RCTs). [6][7][8] TXA is a synthetic analogue of the lysine amino acid that competitively and reversibly binds to plasminogen, 9 rendering it unavailable for lysine residues, 9 thereby preventing the degradation of the fibrin clot. The H&N studies looking at TXA [6][7][8] have demonstrated variable results.…”

Section: Introductionmentioning

confidence: 99%

“…[6][7][8] TXA is a synthetic analogue of the lysine amino acid that competitively and reversibly binds to plasminogen, 9 rendering it unavailable for lysine residues, 9 thereby preventing the degradation of the fibrin clot. The H&N studies looking at TXA [6][7][8] have demonstrated variable results. As a result, the efficacy of TXA use in H&N patients is largely unclear.…”

Section: Introductionmentioning

confidence: 99%

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A systematic review on the efficacy of tranexamic acid in head and neck surgery

Jamshaid

Coulson

et al. 2023

Clinical Otolaryngology

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Background Intraoperative and postoperative blood loss is a major risk in head and neck (H&N) surgery. Recently the use of tranexamic acid (TXA) has been investigated by multiple studies for reducing intraoperative and postoperative bleeding, however reported results are variable. Objectives To determine the safety and efficacy of TXA use in H&N surgery. Methods Systematic review of MEDLINE, EMBASE, CINAHL, Cochrane Library, PubMed, ClinicalKey, and Clinicaltrials.gov according to the PRISMA guidelines. Studies were included if they reported on intraoperative bleeding, volume or duration of postoperative drain or return to theatre rate for postoperative haemorrhage in adult populations following use of TXA. Risk of bias assessment with Cochrane Risk of Bias (RoB2) tool for randomised controlled trials and Newcastle–Ottawa Scale tool for non‐randomised studies. Results Sixteen studies were identified (114 407 patients). Eight studies evaluated TXA in major H&N surgery and eight studies in tonsillectomy. Primary outcomes were reduction in intraoperative or postoperative bleeding. Secondary outcomes included the duration of postoperative drain placement and return to theatre rate. No adverse events were reported in any patients. TXA is effective in reducing intraoperative blood loss in tonsillectomy. However, the effect on posttonsillectomy haemorrhage was unclear. Insufficient evidence exists of benefit of TXA on intraoperative bleeding in major H&N procedures. Postoperative drainage volumes were significantly reduced in most major H&N studies. The duration of drain placement and risk of blood transfusion was unchanged in most cases. Conclusion TXA use is safe in H&N patients. Whilst sufficient evidence exists to support the use of TXA in tonsillectomy, insufficient evidence exists to recommend use in major H&N surgery.

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Tranexamic acid has no advantage in head and neck surgical procedures: a randomised, double-blind, controlled clinical trial

Cited by 8 publications

References 13 publications

Tranexamic acid in ENT

Tranexamic acid in ENT

Can Tranexamic Acid Control Bleeding during and After Total Thyroidectomy? A Randomized Double-blind Clinical Trial Study

A systematic review on the efficacy of tranexamic acid in head and neck surgery

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