Sex disparity in stroke outcomes in a multicenter prospective stroke registry in Vietnam.

BACKGROUND: Although men have a higher rate of stroke than women, it is not clear whether women have a worse outcome after adjusting for confounders such as vascular risk factors, age, stroke severity, and reperfusion therapy. We evaluated sex differences on 90-day functional outcomes after stroke in a multicenter study in Vietnam. METHODS: We recruited patients presenting with ischemic or hemorrhagic stroke at 10 stroke centers in Vietnam for a period of 1 month from 1 August 2022 to 31 August 2022. We reviewed the patient's clinical demographics, time from symptom onset to hospital admission, stroke classification, stroke subtype, stroke severity, characteristics of reperfusion therapy, and 90-day clinical outcome. We compared functional outcomes and predisposing factors at day 90 between men and women after an ischemic and hemorrhagic stroke. Poor outcome was defined as modified Rankin Scale 3-6. RESULTS: There were 2300 stroke patients included. Men accounted for 61.3% (1410) of participants. Compared to men, women were older (67.7 ± 13.9 vs 63.7 ± 13.3, P < 0.001), had a higher rate of diabetes mellitus (21.1% vs 15.3%, P < 0.001), a lower rate of tobacco use (1.0 % vs 23.6%, P < 0.001), and a lower body mass index (21.4 ± 2.70 vs 22.0 ± 2.72, P < 0.001). There was a higher rate of intracranial hemorrhage (ICH) in men (21.3% vs 15.6%, P = 0.001), whereas the rate of subarachnoid hemorrhage was higher in women (6.2% vs 3.0%, P < 0.001). For ischemic stroke, door-to-needle time (36.9 ± 17.6 vs 47.8 ± 35.2 min, P = 0.04) and door-to-recanalization time (113.6 ± 51.1 vs 134.2 ± 48.2, P = 0.03) were shorter in women. There was no difference in 90-day functional outcomes between sexes. Factors associated with poor outcomes included age ⩾50 years (adjusted odds ratio (aOR): 1.75; 95% confidence interval (CI): 1.16-2.66), history of stroke (aOR: 1.50; 95% CI: 1.15-1.96), large artery atherosclerosis (aOR: 5.19; 95% CI: 3.90-6.90), and cardioembolism (aOR: 3.21; 95% CI: 1.68-6.16). Factors associated with mortality in patients with acute ischemic stroke included a history of coronary artery disease (aOR: 3.04; 95% CI: 1.03-8.92), large artery atherosclerosis (aOR: 3.37; 95% CI: 2.11-5.37), and cardioembolism (aOR: 3.15; 95% CI: 1.20-8.27). CONCLUSION: There were no sex differences in the clinical outcome of stroke and ischemic stroke in this prospective cohort of hospitalized Vietnamese patients.

Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial.

RATIONALE: Haematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth. METHODS AND DESIGN: Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework. HYPOTHESIS: In patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo. SAMPLE SIZE ESTIMATES: A sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients. INTERVENTION: Participants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo. PRIMARY EFFICACY MEASURE: The primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan. DISCUSSION: We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.