Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Supratentorial ischaemic stroke, confirmed on imaging 2. Recruited within 48 hours of stroke onset. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was selfreported to be normal 3. NIHSS score 624 with NIHSS 1A (level of consciousness) score <2 at the time of enrolment 4. Reasonable expectation of availability to receive the full course of therapy, and to be available for subsequent follow-up visits 5. Reasonable expectation that patient will receive standard poststroke physical, occupational and speech therapy as indicated
Exclusion criteria
Exclusion criteria: 1. Prestroke modified Rankin Score (mRS) >2 2. Thrombolytic treatment with tPA following the index stroke 3. Patients presenting with hemorrhagic and/or brain stem stroke 4. Women who may be pregnant or breastfeeding 5. Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females), or platelet count > 400,000/mm3 6. Advanced liver, kidney, cardiac or pulmonary disease (serum bilirubin > 1.5 x upper limit of normal (ULN), Alkaline phosphatase > 2.5 x ULN, GGT>2.5xULN 7. History of clotting disorders 8. Expected survival 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy) 13. Preexisting and active major psychiatric or other chronic neurological disease 14. Currently participating in another investigational study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fugl-Meyer scale score from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom