Intravenous Tranexamic Acid in Primary Intracerebral Hemorrhage Trial: A Phase 2 Randomized Control Trial

Area of Science:

• Neurology
• Emergency Medicine
• Pharmacology

Background:

• Limited neurosurgical access in low- and middle-income countries (LMICs) necessitates effective nonsurgical interventions for primary intracerebral hemorrhage (ICH).
• Early medical management of ICH can potentially reduce hematoma expansion and improve patient outcomes.

Purpose of the Study:

• To assess the efficacy of early intravenous tranexamic acid (TXA) in reducing hematoma expansion in primary ICH patients.
• To evaluate the impact of TXA on long-term neurological recovery, survival rates, and healthcare utilization.

Main Methods:

• A phase 2, randomized, double-blind, placebo-controlled trial was conducted.
• 154 primary ICH patients presenting within 24 hours were randomized to receive either intravenous TXA or placebo, alongside blood pressure control.
• Primary outcome was hematoma size change at 48 hours; secondary outcomes included neurological recovery, survival, and complications.

Main Results:

• The TXA group showed a mean reduction in hematoma size (-0.434 mL) versus an increase in the placebo group (0.462 mL) at 48 hours (P=0.038).
• Nonprogression of hematoma was observed in 58.1% of the TXA group vs. 43.7% in the placebo group (NNT=7).
• Mortality at 180 days was significantly lower in the TXA group (25.6%) compared to placebo (38.2%) (P=0.047), with lower surgical intervention rates (15.4% vs. 26.3%, P=0.048).

Conclusions:

• Intravenous TXA administered within 24 hours of primary ICH onset effectively reduces hematoma progression.
• TXA treatment is associated with significantly lower mortality and reduced need for surgical intervention.
• These findings suggest TXA is a safe and beneficial treatment for ICH, particularly in LMICs, warranting further investigation in larger trials.