Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy-a double-blinded randomized placebo-controlled trial.

BACKGROUND: Hysterectomy is one of the most frequently performed major gynecological surgical procedures. Even when the indication for the procedure is benign, relatively high complication rates have been reported. Perioperative bleeding seems to represent the most common cause of complications and in 2004, 8% of all women in Denmark undergoing benign hysterectomy experienced a bleeding complication. Tranexamic acid is an antifibrinolytic agent that has shown to effectively reduce bleeding complications within other surgical and medical areas. However, knowledge about the drug's effect in relation to benign hysterectomy is still missing.

OBJECTIVE: To investigate the antihemorrhagic effect of prophylactic tranexamic acid in elective benign hysterectomy.

STUDY DESIGN: A double-blinded randomized placebo-controlled trial was conducted at 4 gynecological departments in Denmark from April 2013 to October 2014. A total of 332 women undergoing benign abdominal, laparoscopic, or vaginal hysterectomy were included in the trial, randomized to either 1 g of intravenous tranexamic acid or placebo at start of surgery. Chi-square test and Student t test statistical analyses were applied.

RESULTS: The primary outcome of intraoperative total blood loss was reduced in the group treated with tranexamic acid compared to the placebo group when estimated both subjectively by the surgeon and objectively by weight (98.4 mL vs 134.8 mL, P = .006 and 100.0 mL vs 166.0 mL, P = .004). The incidence of blood loss ≥500 mL was also significantly reduced (6 vs 21, P = .003), as well as the use of open-label tranexamic acid (7 vs 18, P = .024). Furthermore, the risk of reoperations owing to postoperative hemorrhage was significantly reduced in the tranexamic acid group compared to the placebo group (2 vs 9, P = .034). This corresponds to an absolute risk reduction of 4.2% and number needed to treat of 24. No incidence of thromboembolic events or death was observed in any of the groups.

CONCLUSION: The results support the hypothesis that prophylactic treatment with tranexamic acid reduces the overall total blood loss, the incidence of substantial blood loss, and the need for reoperations owing to postoperative hemorrhage in relation to benign hysterectomy. No incidences of serious adverse events occurred. Thus, tranexamic acid should be considered as a prophylactic treatment prior to elective benign hysterectomy.