Intraoperative tranexamic acid to decrease blood loss during myomectomy: a randomized, double-blind, placebo-controlled trial - 01/09/20
, Maria V. Vargas, MD a, Cherie Q. Marfori, MD a, Gaby Moawad, MD a, Marloes S. Maasen, MD a, James K. Robinson, MD, MS cAbstract |
Background |
Myomectomy is associated with a significant risk of hemorrhage. Tranexamic acid is a synthetic lysine derivative with antifibrinolytic activity used in other surgical disciplines to reduce blood loss during surgery. However, its utility in gynecologic surgery is not well understood.
Objective |
This study aimed to determine the effect of early administration of intravenous tranexamic acid on perioperative bleeding and blood transfusion requirements in women undergoing myomectomy.
Study Design |
This study was a double-blinded, randomized, placebo-controlled trial conducted in an academic teaching hospital. Women with symptomatic fibroids thought to be at risk for large intraoperative blood loss who met the following criteria were included in the study: (1) at least 1 fibroid ≥10 cm, (2) any intramural or broad ligament fibroid ≥6 cm, and/or (3) at least 5 total fibroids based on preoperative imaging. Patients were randomized to receive a single intravenous bolus injection of tranexamic acid 15 mg/kg (intervention group) versus an intravenous bolus injection of saline of equivalent volume (placebo group) 20 minutes before the initial surgical incision. Perioperative bleeding was defined by measuring intraoperative estimated blood loss, change between pre- and postoperative hemoglobin, and frequency of blood transfusions. Estimated blood loss was calculated by combining the blood volume collected within the suction canister and the weight of used sponges. The 2 groups were compared for age; body mass index; perioperative hemoglobin and hematocrit; perioperative blood loss; duration of surgery; blood transfusion requirements; and the number, total weight, and volume of myomas removed.
Results |
A total of 60 patients (30 per arm) were enrolled into the study between March 1, 2015, and January 29, 2018. Age, body mass index, baseline hemoglobin and/or hematocrit, number and total weight of myomas removed, and size of myomas did not differ between arms. Of 60 patients, 32 (53%) had laparoscopic myomectomy, 24 (40%) had robotic myomectomy, and 4 (7%) had laparotomy. Median estimated blood loss was 200 mL for the tranexamic acid group and 240 mL for the placebo group (P=.88). There was no difference in median duration of surgery (165 vs 164 minutes; P=.64) or change in perioperative hemoglobin (1.00 vs 1.1 g/dL; P=.64). Patients in the tranexamic acid group did not require blood transfusions; however, 4 patients (13.3%) in the placebo group (P=.11) required blood transfusions.
Conclusion |
Intravenous administration of tranexamic acid in patients undergoing laparoscopic or robotic myomectomies was not associated with decreased blood loss.
Le texte complet de cet article est disponible en PDF.Key words : antifibrinolytics, blood loss, fibroids, hemorrhage, myomas, myomectomy, laparoscopy, robotics, tranexamic acid, transfusion
Plan
| Dr Moawad is a speaker for Intuitive Surgical. The other authors report no conflicts of interest. |
|
| This study received financial support from the Clinical and Translational Science Institute at Children’s National (CTSI-CN) Clinical Studies Resource Voucher Award Program. Funding was used to cover the costs of the study drug and procedures performed by the George Washington University Investigational Drug Service. The funding source had no involvement in the study design, data collection, analysis and interpretation of data, report writing, or submission of this publication. |
|
| This study was conducted at the Department of Obstetrics and Gynecology, George Washington University, Washington, DC. The clinical trial identification number for this study is NCT02620748 (NCT02620748?term=tranexamic+acid&cond=fibroids&rank=4). |
|
| Cite this article as: Opoku-Anane, J, Vargas, MV, Marfori, CQ, Moawad, G, Maasen, MS, Robinson, JK. Intraoperative tranexamic acid to decrease blood loss during myomectomy: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol 2020;223:413.e1-7. |
Vol 223 - N° 3
P. 413.e1-413.e7 - septembre 2020 Retour au numéro
Article précédent
- Reproductive and hormonal factors and risk of cognitive impairment among Singapore Chinese women
- Xingyue Song, Jing Wu, Yanfeng Zhou, Lei Feng, Jian-Min Yuan, An Pan, Woon Puay Koh
- Psychiatric comorbidity among women with endometriosis: nationwide cohort study in Sweden
- Menghan Gao, Ilona Koupil, Hugo Sjöqvist, Håkan Karlsson, Sujata Lalitkumar, Christina Dalman, Kyriaki Kosidou
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?