Intravenous tranexamic acid as an adjunct haemostat to ornipressin during open myomectomy. A randomized double blind placebo controlled trial

Abstract

Background: Myomectomy is a surgical technique used for removal of uterine fibroids and historically hysterectomy has represented the mainstay of treatment. The options of conservative surgical approaches mainly aim at retention of fertility but have to be balanced against potential risks such as haemorrhage; blood loss at myomectomy still remains troublesome with use of various pharmacologic agents yielding inconclusive results. This trial aimed to explore the benefit of combining ornipressin and tranexamic acid during open myomectomy.

Study design: A randomized double blind placebo controlled trial.

Methods: Women who satisfied eligibility criteria were enrolled into the study and randomized into one of two groups. The experimental group received 1 g of tranexamic acid diluted to 50 ml of saline administered at 100 ml per hour at cutting time (knife to skin). The control group received placebo diluted to 50 ml of saline administered at 100 ml per hour at cutting time. Both groups had five international units ornipressin diluted in 60 ml of saline administered during surgery. The primary outcome (blood loss) was assessed by determining the weight difference of dry and soaked swabs using a digital weighing scale by converting this to volume (ml). Operating time was noted from the time of uterine incision to the time of uterine closure. The need for transfusion was determined by anaesthetists' assessment of acceptable blood loss and clinical assessment of vital signs. Post-operative stay was calculated from the time of extubation to 8 am on the day of discharge.

Results: A total of thirty-four patients were randomized to two groups; 17 received ornipressin only and 17 received tranexamic acid and ornipressin. There was no difference in blood loss between the groups with a median blood loss in the ornipressin (n = 17) and ornipressin plus tranexamic acid arms of 398 ml (IQR: 251-630) ml and 251 ml (IQR: 158-501) ml respectively P = 0.361.

Conclusions: Ornipressin administered along with tranexamic acid is not beneficial for blood loss reduction at open myomectomy. In settings such as ours where myomata are prevalent and severe anaemia rampant, blood donation and judicious use of scarce blood resources is key. Efforts to optimize preoperative haemoglobin levels and blood auto-donation seem the most promising options in pre-operative preparation prior to myomectomy.

Clinical trials registration number: PACTR201203000369163.

Keywords: Haemorrhage; Myomectomy; Ornipressin; Tranexamic acid.

Figures

Fig. 1

Flow of study participants

Fig. 2

Myoma volume and blood loss