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.

COVID-19 Pandemic Impact on Care for Stroke in Australia: Emerging Evidence From the Australian Stroke Clinical Registry.

We present information on acute stroke care for the first wave of the COVID-19 pandemic in Australia using data from the Australian Stroke Clinical Registry (AuSCR). The first case of COVID-19 in Australia was recorded in late January 2020 and national restrictions to control the virus commenced in March. To account for seasonal effects of stroke admissions, patient-level data from the registry from January to June 2020 were compared to the same period in 2019 (historical-control) from 61 public hospitals. We compared periods using descriptive statistics and performed interrupted time series analyses. Perceptions of stroke clinicians were obtained from 53/72 (74%) hospitals participating in the AuSCR (80% nurses) via a voluntary, electronic feedback survey. Survey data were summarized to provide contextual information for the registry-based analysis. Data from the registry covered locations that had 91% of Australian COVID-19 cases to the end of June 2020. For the historical-control period, 9,308 episodes of care were compared with the pandemic period (8,992 episodes). Patient characteristics were similar for each cohort (median age: 75 years; 56% male; ischemic stroke 69%). Treatment in stroke units decreased progressively during the pandemic period (control: 76% pandemic: 70%, p < 0.001). Clinical staff reported fewer resources available for stroke including 10% reporting reduced stroke unit beds. Several time-based metrics were unchanged whereas door-to-needle times were longer during the peak pandemic period (March-April, 2020; 82 min, control: 74 min, p = 0.012). Our data emphasize the need to maintain appropriate acute stroke care during times of national emergency such as pandemic management.

Presentations of stroke and acute myocardial infarction in the first 28 days following the introduction of State of Emergency restrictions for COVID-19.

OBJECTIVES: To determine if Victorian State of Emergency (SOE) measures to combat COVID-19 were associated with delayed presentations or management of acute stroke and acute myocardial infarction (AMI). METHODS: This was a retrospective, pre- and post-implementation study using data from an adult, tertiary cardiology and neurosciences centre with 24-h capacity for endovascular procedures. All primary presentations with acute stroke or AMI during the first 28 days of stage 2 and stage 3 SOE restrictions (26 March to 23 April 2020) were compared to an equivalent period without restrictions (26 March to 23 April 2019). The primary outcome variable was time from onset of symptoms to ED presentation. RESULTS: There were 52 (1.6% of all ED presentations) patients who met inclusion criteria during the SOE period and 57 (1.0%) patients in the comparator period. Patients were equally matched for demographics, disease severity and prior history of stroke or AMI. Median time from symptom onset to presentation was 227 (93-1183) min during the SOE period and 342 (119-1220) min during the comparator period (P = 0.24). Among eligible patients with ischaemic stroke or ST-elevation AMI, median time to primary reperfusion intervention was 65 (37-78) min during SOE and 44 (39-60) min in the comparator period (P = 0.54). There were no differences in mortality at hospital discharge (9.6% vs 10.5%) and hospital length of stay (5.4 vs 4.3 days). CONCLUSIONS: In the first 28 days, SOE measures to combat COVID-19 were not associated with delays in presentation or life-saving interventions for patients with acute stroke and AMI.