Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy—a double-blinded randomized placebo-controlled trial

Topsoee, Märta Fink; Bergholt, Thomas; Ravn, Pernille; Schouenborg, Lars; Moeller, Charlotte; Ottesen, Bent; Settnes, Annette

doi:10.1016/j.ajog.2016.01.184

Cited by 40 publications

(52 citation statements)

References 22 publications

(24 reference statements)

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“…Topsoee et al in their study on effects of prophylactic TXA treatment in patients undergoing benign hysterectomy had demonstrated significant reduction in perioperative blood loss in TXA treated group. 9 Similar observation was made by Shaaban et al in their study on the efficacy of TXA in reducing blood loss in patients undergoing open myomectomy. 10 Lundin ES et al had observed a mean reduction of estimated blood loss of 248ml in patients undergoing ovarian cancer surgery.…”

supporting

confidence: 62%

“…Topsoee et al and Shady NW et al also had not reported any major adverse events in the TXA treated patients. 9, 33 Goswami et al in their study on effect of TXA on postpartum blood loss had made an observation that inspite of 5-6 times higher incidence of thrombosis during pregnancy and puerperium, no increased risk of thrombosis was found. 28 Similarly, despite the fact that malignancy is a hypercoagulable state, Gupta et al and Lundin ES et al in their study on efficacy of TXA in cancer surgery had revealed no significant incidence of major adverse events.…”

mentioning

confidence: 99%

“…A number of Cochrane systematic reviews conducted in a variety of surgical settings had reported the efficacy of prophylactic perioperative administration of TXA in reducing blood loss and the need for blood transfusion. [6][7][8][9][10] TXA has already been demonstrated to reduce uterine blood loss in non-surgical aspect. Various studies had revealed that TXA resulted in a significant reduction of menstrual blood loss in menorrhagic women while not increasing the risk of thrombosis and had been used successfully to treat menorrhagia associated with a number of coagulopathies.…”

mentioning

confidence: 99%

“…6, 10 Topsoee et al in their randomized controlled trial had concluded that TXA could reduce the total blood loss, the incidence of substantial blood loss, and the need for reoperations for patients who underwent benign hysterectomy. 9 More common adverse events of TXA include nausea, vomiting, diarrhoea, dyspepsia and headache.…”

mentioning

confidence: 99%

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Effect of prophylactic tranexamic acid on blood conservation in Indian women undergoing abdominal hysterectomy

Arthi

Jalakandan

Gunaseelan

2018

Int J Reprod Contracept Obstet Gynecol

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Background: The prevalence of anemia in India is so high that majority of women presenting for hysterectomy are already with borderline hemoglobin status and the perioperative blood loss puts them at risk of death and prolongs recovery. Antifibrinolytic agents, mainly Tranexamic acid (TXA) have been demonstrated to reduce blood loss and transfusion requirements in various surgeries. The present study was done to assess the efficacy of TXA in effectively reducing intraoperative blood loss and the need for transfusion in Indian population undergoing abdominal hysterectomy for benign indications.Methods: This randomized, double-blind, placebo-controlled study was conducted on hundred patients undergoing abdominal hysterectomy. Group T (n = 50)- received TXA 15 mg/kg in 100 ml Normal saline and Group N (n = 50)-received the same volume of Normal saline infused over 15 minutes. Estimated blood loss need for blood transfusion, duration of surgery, postoperative hemoglobin and incidence of adverse events were noted.Results: There was statistically significant reduction in mean blood loss in group T when compared to group N (360 ml versus 540 ml). Accordingly, there was significant difference in the number of patients requiring blood transfusion (12% versus 42%) and also the postoperative hemoglobin levels. The group T patients had a significantly shorter operating time (127.86 versus 148.64 minutes). None of the patients developed any major adverse events.Conclusions: The prophylactic TXA safely and effectively reduces the blood loss and transfusion requirements in Indian patients undergoing abdominal hysterectomy for benign indications.

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supporting

confidence: 62%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Effect of prophylactic tranexamic acid on blood conservation in Indian women undergoing abdominal hysterectomy

Arthi

Jalakandan

Gunaseelan

2018

Int J Reprod Contracept Obstet Gynecol

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“…[7–9] Naoulou et al [7] reviewed all available evidence about the use of TA in menorrhagia and concluded that TA was effective and safe and could potentially improve quality of life of patients with heavy menstrual bleeding. Topsoee et al [8] performed a randomized controlled trail (RCT) and revealed that TA could reduce the total blood loss, the incidence of substantial blood loss, and the need for reoperations for patients who underwent benign hysterectomy. Shaaban et al [9] reported that TA reduced blood loss by a mean volume of 407 mL during and after myomectomy for patients with multiple uterine fibroids.…”

Section: Introductionmentioning

confidence: 99%

Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention?

Gong

Dong

et al. 2017

Medicine

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Background:To assess the efficacy and safety of tranexamic acid (TA) in reducing blood loss and lowering transfusion needs for patients undergoing caesarean section (CS) or vaginal delivery (VD).Methods:An electronic literature search of PubMed, EMBASE, OVID, Cochrane library, Scopus, Central, and Clinical trials.gov was performed to identify studies that evaluating the usage of TA in CS or VD. The methodological quality of included trials was assessed and data extraction was performed.Results:Finally, 25 articles with 4747 participants were included. Our findings indicated TA resulted in a reduced intra-, postoperative, and total blood loss by a mean volume of 141.25 mL (95% confidence interval [CI] −186.72 to −95.79, P < 0.00001), 36.42 mL (95% CI −46.50 to −26.34, P < 0.00001), and 154.25 mL (95% CI −182.04 to −126.47, P < 0.00001) in CS. TA administration in VD was associated with a reduced intra-, postoperative, and total blood loss by a mean volume of 22.88 mL (95% CI −50.54 to 4.77, P = 0.10), 41.24 mL (95% CI −55.50 to −26.98, P < 0.00001), and 84.79 mL (95% CI −109.93 to −59.65, P < 0.00001). In addition, TA could lower the occurrence rate of postpartum hemorrhage (PPH) and severe PPH, and reduce the risk of blood transfusions. No increased risk of deep vein thrombosis (DVT) after CS or VD was associated with TA usage, while the minor side effects were more common.Conclusions:Our findings indicated that intravenous TA for patients undergoing CS was effective and safe. Although prophylactic TA administration is associated with reduced PPH, current existing data are insufficient to draw definitive recommendations about its clinical significance due to the poor to moderate quality of the included literatures. Thus, high-quality randomized controlled trials with larger samples are needed to validate our findings.

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Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality

et al. 2021

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IMPORTANCE Tranexamic acid (TXA) is an efficient antifibrinolytic agent; however, concerns remain about the potential adverse effects, particularly vascular occlusive events, that may be associated with its use.OBJECTIVE To examine the association between intravenous TXA and total thromboembolic events (TEs) and mortality in patients of all ages and of any medical disciplines.DATA SOURCE Cochrane Central Register of Controlled Trials and MEDLINE were searched for eligible studies investigating intravenous TXA and postinterventional outcome published between 1976 and 2020.STUDY SELECTION Randomized clinical trials comparing intravenous TXA with placebo/no treatment. The electronic database search yielded a total of 782 studies, and 381 were considered for full-text review. Included studies were published in English, German, French, and Spanish. Studies with only oral or topical tranexamic administration were excluded.DATA EXTRACTION AND SYNTHESIS Meta-analysis, subgroup and sensitivity analysis, and meta-regression were performed. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. MAIN OUTCOMES AND MEASURES Vascular occlusive events and mortality.RESULTS A total of 216 eligible trials including 125 550 patients were analyzed. Total TEs were found in 1020 (2.1%) in the group receiving TXA and 900 (2.0%) in the control group. This study found no association between TXA and risk for total TEs (risk difference = 0.001; 95% CI, −0.001 to 0.002; P = .49) for venous thrombosis, pulmonary embolism, venous TEs, myocardial infarction or ischemia, and cerebral infarction or ischemia. Sensitivity analysis using the risk ratio as an effect measure with (risk ratio = 1.02; 95% CI, 0.94-1.11; P = .56) and without (risk ratio = 1.03; 95% CI, 0.95-1.12; P = .52) studies with double-zero events revealed robust effect size estimates. Sensitivity analysis with studies judged at low risk for selection bias showed similar results. Administration of TXA was associated with a significant reduction in overall mortality and bleeding mortality but not with nonbleeding mortality. In addition, an increased risk for vascular occlusive events was not found in studies including patients with a history of thromboembolism. Comparison of studies with sample sizes of less than or equal to 99 (risk difference = 0.004; 95% CI, −0.006 to 0.014; P = .40), 100 to 999 (risk difference = 0.004; 95% CI, −0.003 to 0.011; P = .26), and greater than or equal to 1000 (risk difference = −0.001; 95% CI, −0.003 to 0.001; P = .44) showed no association between TXA and incidence of total TEs. Meta-regression of 143 intervention groups showed no association between TXA dosing and risk for venous TEs (risk difference, −0.005; 95% CI, −0.021 to 0.011; P = .53).CONCLUSIONS AND RELEVANCE Findings from this systematic review and meta-analysis of 216 studies suggested that intravenous TXA, irrespective of dosing, is not associated with increased risk of any TE. These results help clarify the incidence of...

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Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy—a double-blinded randomized placebo-controlled trial

Cited by 40 publications

References 22 publications

Effect of prophylactic tranexamic acid on blood conservation in Indian women undergoing abdominal hysterectomy

Effect of prophylactic tranexamic acid on blood conservation in Indian women undergoing abdominal hysterectomy

Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention?

Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality

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