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

Abstract

BackgroundMyomectomy 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 designA randomized double blind placebo controlled trial.MethodsWomen 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.ResultsA 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.ConclusionsOrnipressin 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

Efficacy and safety of tranexamic acid usage in patients undergoing posterior lumbar fusion: a meta-analysis

“…TXA has been widely used in clinical treatment as a hemostatic agent, and it was included on the WHO list as an essential medicine in 2011 [29]. The safety of TXA has been confirmed in obstetric surgery, hip and knee joint replacement, coronary-artery and other surgeries [6–8]. The study of Benoni et al pointed out that TXA does not increase the risk of DVT, and it just inhibits fibrinolysis in the wound to play a hemostasis effect [30].…”

“…TXA can block the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator to delay fibrinolysis and blood clot degradation [4, 5]. This drug has a significant hemostatic effect in obstetric surgery, hip or knee joint replacement, and coronary-artery surgery [6–8]. Previous meta-analyses have shown that TXA can significantly reduce blood loss in spinal surgery [9–12].…”

Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis

“…Tranexamic acid (TXA) is a synthetic amino acid analogue that acts as a competitive inhibitor of plasminogen and finally interferes with fibrinolysis [ 9 ]. TXA can decrease blood loss and reduce transfusion requirements, and has been successfully used in some surgical procedures including THA [ 8 , 10 – 12 ]. Intravenous or topical TXA administration for total hip arthroplasty has been demonstrated to be effective and safe in total hip arthroplasty [ 8 , 13 – 16 ].…”

Abdominal myomectomy: A retrospective review of determinants and outcomes of complications at the University of Ilorin Teaching Hospital, Ilorin, Nigeria

“…Ngichabe et al, in a randomised trial similarly reported on the correlation between myoma volume and blood loss at open myomectomy. 23 In our series, 74.8% of the patients had complications at myomectomy, based on Garry's criteria. 17 Primary intraoperative haemorrhage was the leading complication and 58.2% of the patients required blood transfusion.…”