Does Intravenous Tranexamic Acid Reduce Blood Loss at the Time of Total Colpocleisis? A Randomized Double-Blind Placebo-Controlled Trial.

IF 3.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Journal of minimally invasive gynecology Pub Date : 2025-01-13 DOI:10.1016/j.jmig.2025.01.005
Colleen D McDermott, Danny Lovatsis, Stella Wang, Ella Huszti, Kristin Wadsworth
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Abstract

Objective: To determine the efficacy of intravenous (IV) tranexamic acid (TXA) in reducing blood loss and blood transfusion among women undergoing total colpocleisis.

Design: Double-blind, randomized, placebo-controlled trial.

Setting: Tertiary academic urogynecology practice.

Participants: Consenting women undergoing total colpocleisis (±midurethral sling) for treatment of posthysterectomy pelvic organ prolapse.

Interventions: Participants were randomly assigned to a single dose of 1 gram TXA or placebo after anesthesia induction. Primary outcome measures were the differences in preoperative hemoglobin (hgb) and hematocrit (hct) compared to those measured 24 hours after surgery. Secondary outcomes included the difference in intraoperative blood loss and the need for blood transfusion during hospital stay. Safety outcomes were assessed six weeks postoperatively.

Results: Thirty participants completed the study (TXA: 14; placebo: 16). Preoperative variables were similar between groups. Intraoperative outcomes were also comparable, and all surgeries were completed under general anesthesia. No significant differences were observed in any blood loss outcomes between groups (TXA versus placebo differences: hgb 3.2g/dL versus 2.6g/dL, P=.41; hct 0.09 versus 0.08, P=.25; intraoperative blood loss 340mL versus 405mL, P=.58). One patient in the TXA group received a blood transfusion one day after surgery due to medically significant anemia. There were no significant adverse events related to the study intervention in the TXA group.

Conclusion: This study showed no statistically significant differences in blood loss outcomes with the use of IV TXA at the time of total colpocleisis (±midurethral sling). While TXA administration showed no advantage regarding blood loss, it demonstrated no significant adverse effects. This study reinforces judicious use of TXA at the time of colpocleisis rather than using it prophylactically.

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静脉注射氨甲环酸能减少阴道完全闭锁时的失血量吗?随机双盲安慰剂对照试验。
目的:探讨静脉注射氨甲环酸(TXA)对完全性阴道炎患者减少失血量和输血的效果。设计:双盲、随机、安慰剂对照试验。单位:泌尿妇科专科实习。参与者:自愿接受阴道全切术(±中尿道悬吊)治疗的女性,以治疗乳房切除术后盆腔器官脱垂。干预措施:在麻醉诱导后,参与者被随机分配到单剂量的1克TXA或安慰剂组。主要结局指标是术前血红蛋白(hgb)和红细胞压积(hct)与术后24小时的差异。次要结局包括术中出血量和住院期间输血需求的差异。术后6周评估安全性结果。结果:30名参与者完成了研究(TXA: 14;安慰剂:16)。两组术前变量相似。术中结果也具有可比性,所有手术均在全身麻醉下完成。两组之间的任何失血结果均无显著差异(TXA与安慰剂的差异:hgb 3.2g/dL vs 2.6g/dL, P= 0.41;hct为0.09比0.08,P= 0.25;术中出血量340mL vs 405mL, P= 0.58)。TXA组的一名患者在手术后一天因医学上明显的贫血而接受了输血。在TXA组中没有与研究干预相关的显著不良事件。结论:本研究显示静脉注射TXA对全阴道炎(±中尿道悬吊)时出血量的影响无统计学意义。虽然TXA给药在失血方面没有任何优势,但也没有明显的副作用。这项研究强调在阴道炎时明智地使用TXA,而不是预防性地使用它。
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来源期刊
CiteScore
5.00
自引率
7.30%
发文量
272
审稿时长
37 days
期刊介绍: The Journal of Minimally Invasive Gynecology, formerly titled The Journal of the American Association of Gynecologic Laparoscopists, is an international clinical forum for the exchange and dissemination of ideas, findings and techniques relevant to gynecologic endoscopy and other minimally invasive procedures. The Journal, which presents research, clinical opinions and case reports from the brightest minds in gynecologic surgery, is an authoritative source informing practicing physicians of the latest, cutting-edge developments occurring in this emerging field.
期刊最新文献
Presidential address presented at the 53rd AAGL Global Congress in New Orleans on the 17th of November 2024. Vaginal assisted NOTES hysterectomy for large uterus using the da Vinci SP. Deep endometriosis: beware of the tip of the iceberg. The Impact of Intracervical Terlipressin on Intravasation and Venous Embolization During Transcervical Myomectomy and Endometrium resection: A Randomized Controlled Study. Does Intravenous Tranexamic Acid Reduce Blood Loss at the Time of Total Colpocleisis? A Randomized Double-Blind Placebo-Controlled Trial.
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