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.
Background: The data on the relationship between statin use and clinical outcomes after intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) are in controversy.Objective: This systematic review and meta-analysis aimed to evaluate the safety and efficacy of statins administered prior to onset and during hospitalization in patients with AIS treated with IVT.Methods: We searched PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials from inception until June 8, 2021. Comparative studies investigating statin effect on intracranial hemorrhage (ICH), functional outcomes, and mortality in adults with AIS treated with IVT were screened. Random-effect meta-analyses of odds ratios (ORs) with corresponding 95% confidence intervals (CIs) were performed. The protocol was registered in PROSPERO (CRD42021254919).Results: Twenty-two observational studies were included, which involved 17,554 patients. The pooled estimates showed that pre-stroke statin use was associated with a higher likelihood of symptomatic ICH (OR 1.31; 95% CI 1.07–1.59; p = 0.008) and any ICH (OR 1.21; 95% CI 1.03–1.43; p = 0.02). However, the pre-stroke statin use was not significantly associated with the 3-month mortality, 3-month favorable functional outcome (FFO, modified Rankin Scale [mRS] score 0–1), and 3-month functional independence (FI; mRS score 0–2). However, in-hospital statin use was associated with a reduced risk of symptomatic ICH (OR 0.46; 95% CI 0.21–1.00; p = 0.045), any ICH (OR 0.51; 95% CI 0.27–0.98; p = 0.04), and 3-month mortality (OR 0.42; 95% CI 0.29–0.62; p < 0.001) and an increased probability of 3-month FFO (OR 1.33; 95% CI 1.02–1.744; p = 0.04) and 3-month FI (OR 1.41; 95% C, 1.11–1.80; p = 0.005).Conclusions: The present systematic review and meta-analysis suggests that in-hospital statin use after IVT may be safe and may have a favorable impact on clinical outcomes, a finding not observed in studies restricted to patients with pre-stroke statin use.
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