STOP-MSU
(2024)Objective
To determine whether intravenous tranexamic acid administered within 2 hours of spontaneous intracerebral haemorrhage symptom onset reduces haematoma growth compared with placebo.
Study Summary
• Haematoma growth occurred in 38% of placebo vs 43% of TXA group (aOR 1.31, 95% CI 0.72-2.40; p=0.37) — no significant difference
• No differences in secondary imaging endpoints (absolute/relative growth, IVH growth) or functional outcomes (mRS at 90 days)
• Mortality at 90 days was numerically higher with TXA (18% vs 15%) but not statistically significant (aOR 1.61, 95% CI 0.65-3.98)
• TXA was safe with no significant increase in thromboembolic events (3% TXA vs 1% placebo); no deaths attributed to study treatment
• No differences in secondary imaging endpoints (absolute/relative growth, IVH growth) or functional outcomes (mRS at 90 days)
• Mortality at 90 days was numerically higher with TXA (18% vs 15%) but not statistically significant (aOR 1.61, 95% CI 0.65-3.98)
• TXA was safe with no significant increase in thromboembolic events (3% TXA vs 1% placebo); no deaths attributed to study treatment
Intervention
Intravenous tranexamic acid 1 g over 10 min followed by 1 g over 8 h, commenced within 2 hours of symptom onset, versus matched placebo (normal saline).
Inclusion Criteria
Adults >=18 years with acute spontaneous ICH confirmed on non-contrast CT, able to receive treatment within 2 h of stroke onset.
Study Design
Arms: 1:1 randomization — Tranexamic acid arm (IV TXA 1 g bolus over 10 min + 1 g infusion over 8 h) vs Placebo arm (matched IV normal saline over same schedule).
Patients per Arm: Tranexamic acid: 103; Placebo: 98
Outcome
• Primary: Haematoma growth (>=33% relative or >=6 mL absolute on 24 h CT) — 43% TXA vs 38% placebo (aOR 1.31, 95% CI 0.72-2.40; p=0.37)
• mRS <3 at 90 days: 30% TXA vs 32% placebo (aOR 0.77, 95% CI 0.38-1.56)
• mRS <4 at 90 days: 51% TXA vs 48% placebo (aOR 1.03, 95% CI 0.53-2.01)
• Death at 7 days: 8% in both groups (aOR 1.08)
• Death at 90 days: 18% TXA vs 15% placebo (aOR 1.61, 95% CI 0.65-3.98)
• Major thromboembolic events: 3% TXA vs 1% placebo (risk difference 0.02, 95% CI -0.02 to 0.06)
• mRS <3 at 90 days: 30% TXA vs 32% placebo (aOR 0.77, 95% CI 0.38-1.56)
• mRS <4 at 90 days: 51% TXA vs 48% placebo (aOR 1.03, 95% CI 0.53-2.01)
• Death at 7 days: 8% in both groups (aOR 1.08)
• Death at 90 days: 18% TXA vs 15% placebo (aOR 1.61, 95% CI 0.65-3.98)
• Major thromboembolic events: 3% TXA vs 1% placebo (risk difference 0.02, 95% CI -0.02 to 0.06)