Abstract
Background: The role of tranexamic acid (TXA) in preventing hematoma expansion (HE) in patients with acute spontaneous intracerebral hemorrhage (ICH) remains unclear. We aim to investigate the efficacy and safety of TXA in acute spontaneous ICH with a particular focus on subgroups.Methods: Randomized controlled trials (RCTs) were retrieved from CENTRAL, Clinicaltrials.gov, EMBASE, PubMed, and WHO ICTRP. The primary outcome measurement was HE. The secondary outcome measurements included 3-month poor functional outcome (PFO), 3-month mortality, and major thromboembolic events (MTE). We conducted subgroup analysis according to the CT markers of HE (standard-risk population and high-risk population) and the time from onset to randomization (>4.5 and ≤4.5 h).Results: We identified seven studies (representing five RCTs) involving 2,650 participants. Compared with placebo, TXA may reduce HE on subsequent imaging (odd ratio [OR] 0.825; 95% confidence interval [CI] 0.692–0.984; p = 0.033; I2 = 0%; GRADE: moderate certainty). TXA and placebo arms did not differ in the rates of 3-month PFO, 3-month mortality, and MTE. Subgroup analysis indicated that TXA reduced the risk of HE in the high-risk population with CT markers of HE (OR 0.646; 95% CI 0.503–0.829; p = 0.001; I2 = 0 %) and in patients who were treated within 4.5 h of symptom onset (OR 0.823; 95% CI 0.690–0.980; p = 0.029; I2 = 0%), but this protective effect was not observed in the standard-risk population and patients who were treated over 4.5 h of symptom onset.Conclusions: Tranexamic acid (TXA) may decrease the risk of HE in patients with acute spontaneous ICH. Importantly, the decreased risk was observed in patients who were treatable within 4.5 h and with a high risk of HE, but not in those who were treatable over 4.5 h and in standard-risk population. However, PFO or mortality at 3 months did not significantly differ between patients who received TXA and those who received placebo. TXA is safe for acute spontaneous ICH without increasing MTE.
Highlights
Spontaneous intracerebral hemorrhage (ICH) is one of the leading causes of disability and death worldwide, and is one of the serious global public health and socioeconomic burdens
We considered studies to be eligible if they met the following criteria: (i) Types of studies: randomized controlled trials (RCTs) published in peer-reviewed medical journals; (ii) Types of participants: Adult patients with spontaneous ICH and are treatable within 24 h of symptom onset; (iii) Types of interventions: tranexamic acid (TXA) at any dose versus placebo; (iv) Types of outcome measures: The outcome measurements were hematoma expansion (HE), 3-month poor functional outcome (PFO; defined as modified Rankin Scale score 4–6), 3-month mortality, and major thromboembolic events (MTE; according to the definition provided in each study)
Subgroup analyses indicated that TXA reduced the risk of HE in the high-risk population and patients who were treatable within 4.5 h of symptom onset, but not in the standard-risk population, and patients who were treatable over 4.5 h of symptom onset
Summary
Spontaneous intracerebral hemorrhage (ICH) is one of the leading causes of disability and death worldwide, and is one of the serious global public health and socioeconomic burdens. Neurological deficit, hemorrhage cause, location, and hematoma volume are the main determinants of clinical outcomes in patients with ICH [5, 6]. Tranexamic acid (TXA) therapy is theoretically more suitable for patients with high-risk for ICH growth, such as patients with early computed tomography (CT) markers of HE. It seems feasible to identify patients at high risk for HE early, and for early therapeutic intervention to improve the clinical outcomes of patients with acute spontaneous ICH. The role of tranexamic acid (TXA) in preventing hematoma expansion (HE) in patients with acute spontaneous intracerebral hemorrhage (ICH) remains unclear. We aim to investigate the efficacy and safety of TXA in acute spontaneous ICH with a particular focus on subgroups
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