IVIG in Acute Ischemic Stroke: A Pilot Study "IVIG/AIS"

Withdrawn

Phase 1 Results N/A

Update History

28 Mar '13
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Onset of neurological symptoms between 4.5 and 8 hours 2. Male or Female age 45 -75 years old 3. Score of 10-15 points on the National Institutes of Health Stroke Scale (NIHSS) with clinical signs suggestive of ischemic stroke 4. Acute brain ischemia with a distinct penumbra (at least 20%), measured by magnetic resonance perfusion imaging (PI) and diffusion-weighted imaging (DWI), in the territory of the middle cerebral artery, anterior cerebral artery, or posterior cerebral artery with a hemispheric distribution 5. Ability and willingness to provide informed consent and comply with study requirements and procedures Exclusion Criteria: 1. Eligibility for acute thrombolytic (rtPA) treatment 2. Normal brain MRI 3. Transient ischemic attack or rapidly improving neurological symptoms 4. Previous disability 5. Hemorrhagic stroke on brain MRI (T2*/SWI) 6. Ongoing infection defined by clinical and laboratory signs: an evidence-based guideline will be followed to detect infectious complications (in short, physical and laboratory measures including WBC, ESR, hsCRP, PCT, fever, abnormal urine, chest X-ray or positive cultures) 7. Diagnosis of malignancy 8. Known sensitivity to any ingredients in the study drug or radiological contrast material 9. Participation in another clinical trial within the past 30 days 10. Stroke in the previous 3 months 11. Chronic liver, kidney or hematological disease 12. Contraindications to MRI -Brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body e.g. metal shavings, other implanted medical devices: (e.g. Swan Ganz catheter) insulin pump, metal shrapnel or bullet. 13. Diabetes 14. Hypertension 15. Females who are pregnant or breastfeeding
Old
Inclusion Criteria: 1. Onset of neurological symptoms between 4.5 and 8 hours 2. Male or Female age 45 -65 years old 3. Score of 10-15 points on the National Institutes of Health Stroke Scale (NIHSS) with clinical signs suggestive of ischemic stroke 4. Acute brain ischemia with a distinct penumbra (at least 20%), measured by magnetic resonance perfusion imaging (PI) and diffusion-weighted imaging (DWI), in the territory of the middle cerebral artery, anterior cerebral artery, or posterior cerebral artery with a hemispheric distribution 5. Ability and willingness to provide informed consent and comply with study requirements and procedures Exclusion Criteria: 1. Eligibility for acute thrombolytic (rtPA) treatment 2. Normal brain MRI 3. Transient ischemic attack or rapidly improving neurological symptoms 4. Previous disability 5. Hemorrhagic stroke on brain MRI (T2*/SWI) 6. Ongoing infection defined by clinical and laboratory signs: an evidence-based guideline will be followed to detect infectious complications (in short, physical and laboratory measures including WBC, ESR, hsCRP, PCT, fever, abnormal urine, chest X-ray or positive cultures) 7. Diagnosis of malignancy 8. Known sensitivity to any ingredients in the study drug or radiological contrast material 9. Participation in another clinical trial within the past 30 days 10. Stroke in the previous 3 months 11. Chronic liver, kidney or hematological disease 12. Contraindications to MRI -Brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body e.g. metal shavings, other implanted medical devices: (e.g. Swan Ganz catheter) insulin pump, metal shrapnel or bullet. 13. Diabetes 14. Hypertension 15. Females who are pregnant or breastfeeding
A location was updated in Falls Church.
New
The overall status was removed for Inova Health Systems; Inova Fairfax Hospital.