I63.4
Conditions
Interventions
Group 1: Dosis of GSC-F (Filgrastim, Neupogen (R)):
subcutaneous injection of 2.5ug/kg (body weight) over 5 days
Group 2: Dosis of GSC-F (Filgrastim, Neupogen (R)) if no toxicity at previous dose:
sub
Sponsors
Klinik für Neurologie, Universität Regensburg, Bezirksklinikum Regensburg
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Acute ischemic stroke with NIHSS 4-22 middle cerebral artery territory (M2-branch occlusion); - dominant and non-dominant hemisphere - Informed and written consent - inclusion into study within 12hrs of symptom onset - age = 18 yrs = 60 yrs - normal liver function (transaminases such as GOT, GPT, ?GT) not exceeding 3x of normal values, bilirubin < 1.5 mg/dl - normal bone marrow function (platelets and leucocytes within normal range) - good expected compliance
Exclusion criteria
Exclusion criteria: - treatment with abciximab (Rheopro (R)) - IV thrombolysis in the past 14 days but not IV thrombolysis for current event - participant in any other investigational study - global aphasia - expected operation within the next days - interal carotid artery pseudoocclusion or ulcerated carotid plaque - suspected vasculitis - dissection of brain supplying arteries - pregnancy - residual neurologic deficit from previous stroke (either hemorrhagic or ischemic) - immunosuppressive therapy (such as glukocorticoids) - hematologic disease (such as myeloproliferative disease) - platelet dysfunction - non-controlled metabolic state (such as diabetes or hyperlipidemia) - uncontrolled arterial hypertension - any coagulation disorder - severe coronary artery disease - spheroid cell anemia - any severe ongoing malignant disease - severe psychiatric disorder (depression, psychosis, addictive syndromes) - high grade myocardial insufficiency - positive for HIV - any malignant cancer - known allergy against G_CSF - heavy smoking, more than 20 cigarettes per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity and tolerance to G-CSF in stroke patients. Adverse events classified as - continuos fever > 38.5°C - thrombocytosis >500.000/uL with clinical and neurological worsening - continuous leucocytosis > 50,000 /µl with systemic or clinical-neurological worsening - any sort of acute CNS damage not related to stroke in MCA territory - recurrent strokes within 14days not to be attributed to patients cardiovascular disease - significant CNS hemorrhages within 14 days - any kind of systemic toxicity of unkown origin | — |
Secondary
| Measure | Time frame |
|---|---|
| • Functional outcome parameters in stroke patients following G-CSF Therapy; repetitive NIHSS, mod. Rankin Scale; Barthel index; FIM-Score at study inclusion and at 24 hours and at days 7, 28 and 90 • Morphometric changes using MRI and voxel-guided morphometry from this dataset at day 1-3, day 7 and day 90 post stroke • Quality of Life SSQL at the end of the study • Neuropsychology at day 7 | — |
Countries
Germany
Contacts
Public ContactSandra Boy
Klinik für Neurologie, Universität Regensburg, Bezirksklinikum Regensburg
Outcome results
None listed