Intravenous tranexamic acid use in myomectomy: A prospective randomized double-blind placebo controlled study

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Abstract

Objective

To define the effect of tranexamic acid use on perioperative and postoperative bleeding and blood transfusion requirements in women undergoing myomectomy.

Study design

Among the patients that underwent myomectomy a total of 100 cases were included in the study. The patients (n = 50) randomized to receive tranexamic acid were defined as Group I and those receiving saline were defined as Group II. Perioperative blood loss was calculated by measuring the volume in the suction apparatus and weighing the swabs. Postoperative blood loss was defined as the blood volume found in the subfascial suction drain. The two groups were compared for age, body mass index, basal hemoglobin and hematocrit, basal parameters of coagulation, the number and the volume of myomas removed, peri- and postoperative and total blood loss, duration of surgery and blood transfusion requirements.

Results

No significant difference was found between the two groups when compared age, body mass index, preoperative blood analysis, the number and volume of myomas removed. Statistically significant differences were found between the two groups when compared for postoperative and total blood loss and duration of surgery (p < 0.01, p = 0.03 and p = 0.03, respectively). Perioperative blood loss and blood transfusion requirements were similar between the two groups (p = 0.12 and p = 0.25, respectively). There were no complications in either group.

Conclusion

Our study is the first in the literature evaluating the effectiveness of tranexamic acid use on peri- and postoperative bleeding in gynecological surgery. No additional benefit of intravenous infusion of tranexamic acid was found. Tranexamic acid does not seem to be a useful adjunct in myomectomy if given according to the described protocol in this study.

Introduction

All surgical procedures are associated with bleeding, the amount of which depends on surgical and non-surgical factors. Myomectomy is one of the gynecological operations associated with significant blood loss. In most cases, adequate surgical haemostasis is provided with advanced surgical techniques, along with blood transfusion therapy which makes myomectomy an alternative operation to hysterectomy in cases with symptomatic leiomyomata requiring surgery [1]. However, excess perioperative bleeding remains a major complication following myomectomy that might necessitate hysterectomy resulting in increased morbidity and mortality. In such cases, pharmacological interventions may be of additional benefit. Pharmacological manipulation of the coagulation cascade with antifibrinolytic treatment, especially aprotinin, tranexamic acid (TA), epsilon-aminocaproic acid, desmopressin and recombinant factor VIIa are being used both in prophylaxis and therapeutically to stop bleeding [2].

Tranexamic acid, a synthetic lysine derivative with antifibrinolytic activity has been used since 1960s in a variety of clinical settings where antifibrinolytic therapy is appropriate [3]. TA has been used to reduce blood loss and to reduce the need for allogeneic blood transfusion especially in cardiac surgery, liver transplantation and some orthopedic surgical procedures, with variable results [4].

Lack of scientific evidence on the use of antifibrinolytic agent TA in patients undergoing gynecological surgery promoted us to conduct this study. To define an effective and safe pharmacological therapy for reducing blood loss and transfusion requirements, we evaluated the effect of TA on peri- and postoperative bleeding and the number of blood transfusions needed in women undergoing myomectomy.

Section snippets

Materials and methods

The number of patients needed for this study were calculated on the basis of the previous report by Benoni et al. [5] who had reported an average reduction in blood loss of 255 ml in cases receiving tranexamic acid. A sample size of 50 per group was required to detect a 250 ml difference according to preoperative blood loss between groups with a power of 85% at the 5% significance level. In the Department of Gynecology, a total of 167 patients underwent myomectomy between 1 March 1 and 30

Results

The mean age of the patients were 35.3 ± 5 years (ranged from 23 to 40). Twelve of the cases had a medical history of previous abdominal surgery including laparoscopy in four, appendectomy in two, cesarean section in four and myomectomy in two patients (six in each group). Most of the operations were performed via pfannestiel incision; in 15 cases midline vertical incision were performed (7 in TA and 8 in saline group).

Table 1 summarizes the patient characteristics, preoperative blood analysis,

Comment

In practice, TA is used in a variety of clinical settings in which antifibrinolytic activity is thought to be beneficial. TA is used in gynecology and obstetrics in different hemorrhagic conditions. Most commonly, it is used for treatment of idiopathic menorrhagia, which is an effective and well tolerated treatment when administered orally [3]. Bleeding associated with pregnancy (placental abruption, placenta previa) has also been treated with TA [6], [7], [8]. Moreover, oral administration of

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