Regeneration in acute stroke
- Conditions
- I63.4Cerebral infarction due to embolism of cerebral arteries
- Registration Number
- DRKS00000723
- Lead Sponsor
- Klinik für Neurologie, Universität Regensburg, Bezirksklinikum Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicity and tolerance to G-CSF in stroke patients. Adverse events classified as <br>- continuos fever > 38.5°C<br>- thrombocytosis >500.000/uL with clinical and neurological worsening<br>- continuous leucocytosis > 50,000 /µl with systemic or clinical-neurological worsening <br>- any sort of acute CNS damage not related to stroke in MCA territory<br>- recurrent strokes within 14days not to be attributed to patients cardiovascular disease<br>- significant CNS hemorrhages within 14 days<br>- any kind of systemic toxicity of unkown origin
- Secondary Outcome Measures
Name Time Method • 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<br>• Morphometric changes using MRI and voxel-guided morphometry from this dataset at day 1-3, day 7 and day 90 post stroke <br>• Quality of Life SSQL at the end of the study<br>• Neuropsychology at day 7