Intravenous Tranexamic Acid Reduces Perioperative Blood Loss in Mastectomy With Immediate Implant-Based Reconstruction: A Randomized, Triple-Blinded, Placebo-Controlled Trial.

Abstract

Postoperative hematoma and oozing can compromise outcomes after mastectomy with immediate reconstruction. Intravenous tranexamic acid (TXA) is antifibrinolytic, but prospective evidence in this setting is limited. To determine whether a single pre-incision dose of intravenous TXA reduces perioperative blood loss and fibrinolytic activation versus placebo. In this randomized, triple-blinded, placebo-controlled trial, 60 women (ASA I-II, 18-75 years) undergoing bilateral mastectomy with immediate implant-based reconstruction received TXA 10 mg/kg in 100 mL saline or placebo 10 min before incision. The primary outcome was total blood loss within 24 h (intraoperative suction+swab plus drain output). Secondary outcomes were perioperative change in hemoglobin, D-dimer and fibrinogen, and complications within 30 days. Intention-to-treat analyses were performed. All patients completed follow-up. Total blood loss was lower with TXA than with placebo (mean ± SD: 221.1 ± 72.4 vs. 298.1 ± 90.6 mL; mean difference -77.0 mL; 95% CI -122.4 to -31.6; p=0.001). Intraoperative loss and 24-hour drain output were also reduced. Postoperative D-dimer rise was attenuated with TXA (0.31 ± 0.15 vs. 0.49 ± 0.22 µg/mL; p=0.002); hemoglobin decline was smaller. No thromboembolic, neurologic, or allergic events occurred; no skin-flap necrosis was observed. Pre-incisional intravenous TXA safely reduces perioperative bleeding and fibrinolytic activity after mastectomy with immediate implant-based reconstruction. These findings suport incorporation of IV TXA into perioperative protocols.