Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized Trial [22E

Abstract

INTRODUCTION: Intravenous tranexamic acid (TXA) is routinely used in orthopedic and cardiac surgery to reduce blood loss. There is growing evidence supporting off-label use in obstetrical hemorrhage, yet no prior studies have investigated TXA for deliveries complicated by placenta previa and/or accreta. METHODS: This was a single site, randomized, placebo-controlled, double blind pilot study from 11/2016 to 7/2018. Eligible participants were women with suspicion of morbidly adherent placenta (accreta) on imaging, or women with placenta previa and two or more cesareans (CS). Subjects were randomized to receive 1 gram of IV TXA vs placebo at cord clamping during their cesarean or cesarean hysterectomy (CH). RESULTS: The TXA (n=6) and placebo (n=5) groups were well matched for age, parity and number of prior cesareans. Mean gestational age was 35w0d in the TXA group and 34w2d for placebo. The TXA group had 2 CH for accreta and 4 CS for previa, while the placebo group had 4 CH and 1 CS. Mean estimated blood loss (EBL) was 3,116 cc (SD 3,947) in the TXA group and 9,420 cc (SD 12,474) in the placebo group (P>.3). The mean pRBCs units given intraoperatively was 5.2 (SD 8) in TXA group and 17.6 (SD 25) for placebo. In all study participants, no thrombotic events occurred. CONCLUSION: The sample size was insufficient to evaluate the primary endpoint of EBL. However, no complications attributable to giving TXA at cord clamping were encountered. Power analysis suggests n=36 in both groups would be sufficient in future studies to detect a difference in EBL.