- Design
- Randomised, double-blind, placebo-controlled trial
- Population
- 185 patients with severe obesity undergoing elective laparoscopic sleeve gastrectomy
- Primary outcome
- Perioperative bleeding and 24-hour haemoglobin
- Effect
- Intraoperative bleeding 1% vs 5.5% (p = 0.012); Hb 12.5 vs 11.1 g/dL
In this double-blind randomised trial, 185 patients with severe obesity undergoing elective laparoscopic sleeve gastrectomy received tranexamic acid or placebo before surgery.
Intraoperative bleeding was less frequent with tranexamic acid (1% vs 5.5%), and haemoglobin at 24 hours was higher (12.5 vs 11.1 g/dL). Transfusion requirements, haemodynamic stability and length of stay did not differ. No thromboembolic events occurred in either group.
The trial is small and single-country, and the absence of thrombosis in 93 treated patients cannot rule out a rare risk in a population already at high thrombotic risk. Staple-line bleeding is the commonest early complication of sleeve gastrectomy, so a cheap, familiar drug that reduces it is worth considering, alongside — not instead of — careful staple-line technique and standard thromboprophylaxis.
- Consider a single preoperative dose of tranexamic acid for laparoscopic sleeve gastrectomy.
- Keep standard mechanical and pharmacological thromboprophylaxis in place.
- Exclude patients with prior venous thromboembolism or other contraindications to tranexamic acid.
- Transfusion rates did not fall in this trial, so the benefit is fewer bleeds rather than fewer units given.
Why it matters
Staple-line bleeding is the commonest early problem after sleeve gastrectomy, and this targets it with an inexpensive drug.
Don't overread it
Too small to establish thrombotic safety in a high-risk bariatric population.
The statistics, in plain English
Bleeding fell from about 1 in 18 patients to about 1 in 100. With only 185 patients, the trial was too small to detect a rare increase in thrombosis, so 'no events' is reassuring but not proof of safety.
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