IVIG in Acute Ischemic Stroke: A Pilot Study

Withdrawn before enrolling · Phase 1

Conditions studied: Ischemic Stroke

In brief

The purpose of the study is to evaluate the ability of IVIG to affect the rate of progression of brain ischemia, as evidenced by neuroimaging. The results of an ongoing epidemiological study indicate that patients with primary immunodeficiency (PID) on IVIG replacement therapy have an overall prevalence of stroke that is 5 times less than in the general population. Even more striking is the absence of stroke in IVIG-treated PID patients over 65, while in the same general population age group the stroke prevalence goes up to 8.1%. This suggests that the degree of stroke protection correlates with the length of IVIG treatment, since older PID patients have been treated with IVIG significantly longer than younger ones.

Key facts

Study ID

NCT01628055

Run by

Inova Health Care Services

People needed

0

Starts

2013-03-01

Expected to finish

2013-09-01

Last updated by the study team

2013-11-11

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Onset of neurological symptoms between 4.5 and 8 hours
• Male or Female age 45 -75 years old
• Score of 10-15 points on the National Institutes of Health Stroke Scale (NIHSS) with clinical signs suggestive of ischemic stroke
• 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
• Ability and willingness to provide informed consent and comply with study requirements and procedures

You may not qualify if…

• Eligibility for acute thrombolytic (rtPA) treatment
• Normal brain MRI
• Transient ischemic attack or rapidly improving neurological symptoms
• Previous disability
• Hemorrhagic stroke on brain MRI (T2*/SWI)
• 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)
• Diagnosis of malignancy
• Known sensitivity to any ingredients in the study drug or radiological contrast material
• Participation in another clinical trial within the past 30 days
• Stroke in the previous 3 months
• Chronic liver, kidney or hematological disease
• 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.
• Diabetes
• Hypertension
• Females who are pregnant or breastfeeding

Where it is running

• Inova Health Systems; Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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