Acute stroke Circulatory System
Conditions
Interventions
Baseline clinical characteristics performed following consent (including past medical history, prior level of independence, current stroke severity (NIHSS), risk factors and swallow status), current a
Sponsors
Salford Royal NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stroke patients: 1. Age =18 years 2. Clinical diagnosis of middle cerebral artery (MCA) territory ischaemic stroke or haemorrhage stroke (primary intracerebral haemorrhage) 3. NIHSS =8 4. Swallowing difficulties identified on swallow screen performed within 24h of stroke admission 5. Capacity to give consent to blood sampling and follow-up OR availability of personal/professional consultee 6. Blood draw can be undertaken 24-48h after stroke onset (or time last seen well) Non-stroke controls: Aged over 18 Added 15/06/2020: COVID-19 sub-study: 1. Age =18 2. Clinical diagnosis ischaemic stroke or haemorrhagic stroke (primary intracerebral haemorrhage; ICH) in any cerebral territory 3. Suspected or confirmed diagnosis of COVID-19 (either prior to stroke admission or within 7 days of stroke onset)* 4. NIHSS >2 (regardless of swallow status) 5. Capacity to give consent to participation or verbal declaration from personal consultee prior to blood sampling 6. Blood draw can be undertaken within 7 days of stroke onset (or time last seen well)
Exclusion criteria
Exclusion criteria: Stroke patients: 1. Stroke of other aetiology or unclear diagnosis (e.g. traumatic, stroke mimic) 2. Rapidly improving symptoms at the point of screening 3. History of infection treated with antibiotics at admission or in the preceding 6 weeks 4. Unlikely to survive or palliative care considered to be imminent Non-stroke controls: 1. Previous stroke 2. Infection or antibiotic therapy in previous 6 weeks Added 15/06/2020: COVID-19 sub-study: 1. Stroke of other aetiology or unclear diagnosis (e.g. traumatic, stroke mimic) 2. Rapidly improving symptoms at the point of screening 3. Unlikely to survive or palliative care considered to be imminent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Numbers and composition of blood B cell subsets and key immune cell classes, measured using flow cytometry at 24-48h post stroke onset in stroke patients 2. Concentration of blood IgM and catecholamines (noradrenaline and adrenaline), measured using multiplex array, ELISA, EIA and HPLC (high-performance liquid chromatography) at 24-48h post stroke onset in stroke patients and in non-stroke controls 3. Functional responsiveness (e.g. antibody secretion) of blood B cells measured by ex vivo stimulation assay at 24-48h post stroke onset in stroke patients and in non-stroke controls Added 15/06/2020: 4. Immunological characteristics/markers associated with vulnerability to COVID-19 (sub-study participants only) using multiplex array, ELISA, EIA and HPLC (high-performance liquid chromatography) within 7 days post-stroke onset | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of Stroke-Associated Infection (SAI) based on Centers for Disease Control and Prevention [CDC] criteria at 3 months 2. Clinical outcome assessed with telephone assessment of modified Rankin Scale score at 3 months | — |
Countries
England, United Kingdom
Outcome results
None listed