Ischaemic stroke Circulatory System Stroke
Conditions
Interventions
Subcutaneous human recombinant G-CSF (Filgrastrim 1 x 106 u/kg) versus saline started three to 30 days after stroke onset and given for five days.
Sponsors
University of Nottingham (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical stroke (lacunar or cortical) 2. Ischaemic or haemorrhagic type on neuro-imaging three to 30 days post-onset 3. Arm and/or leg weakness (Scandinavian Stroke Scale [SSS] arm and/or leg motor power less than six)
Exclusion criteria
Exclusion criteria: Prior to 09/09/09: 1. Pre-morbid dependency, modified Rankin Scale (mRS) more than three 2. Primary intracerebral haemorrhage 3. Dementia 4. Coma (SSS consciousness less than four) 5. Malignancy 6. Sickle cell disease 7. Pregnancy (see data sheet/British National Formulary [BNF] for other G-CSF contra-indications) 8. Known contra-indication to Magnetic Resonance Imaging (MRI) Amended 09/09/09: 1. Pre-morbid dependency, modified Rankin Scale (mRS) more than three 2. Dementia 3. Coma (SSS consciousness less than four) 4. Malignancy 5. Sickle cell disease 6. Pregnancy (see data sheet/British National Formulary [BNF] for other G-CSF contra-indications) 7. Known contra-indication to Magnetic Resonance Imaging (MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients having a serious adverse event by day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Laboratory measures including CD34+ count 2. Clinical efficacy: 2.1. Impairment 2.2. Dependency disability 2.3. Functional independence 2.4. Quality of life 3. Length of stay in hospital, discharge disposition 4. Neuroimaging: including lesion size 5. Feasibility | — |
Countries
United Kingdom
Outcome results
None listed