Neurosurgical Clinical Trial Unit - ARUBA

Newcastle Neurosurgery Clinical Trials Unit	Neurosurgical Clinical Trial Unit

Neurosurgical Clinical Trial Unit - ARUBA

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click on the logo to go to the relevant external trial webpage	ARUBA
	International randomised trial of unruptured brain arteriovenous malformations comparing intervention with conservative treatment. ARUBA's goal is to test the null hypothesis that treatment, by means of interventional procedures, surgery, or radiotherapy offers no difference in the risk of death or symptomatic stroke, and no better functional outcome than does conservative management at five years from discovery of an unruptured brain arteriovenous malformation (BAVM).
	Brief inclusion / exclusion criteria
About ARUBA Protocol Overview (slides) Contact Information Patient Selection Eligibility Evaluation Randomisation Form Imaging Study - Part 1 Imaging Study - Part 2 Demographic Survey Screening Log Forms - Newcastle only Patient Information Sheet - Part 1 Patient Information Sheet - Part 2 Patient Consent Form	Inclusion: Unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram Patient must be 18 years or older Patient must have signed the Informed Consent Form Exclusion: Evidence or recent or previous haemorrhage Patient has received BAVM therapy previously - endovascular, surgical or radiotherapy BAVM is deemed untreatable or contraindications for interventional therapy Baseline Rankin of ≥ 2 Concomitant disease reducing life expectancy to less than 10 years Uncorrectable coagulopathy - INR > 1.5 Pregnancy Multiple-foci BAVMs Patient has known allergy against iodine contrast agents

Staff Involved	Principal Investigators:	Dr J.P. Mohr (New York) Dr. C. Stapf (Paris) Prof. A.D. Mendelow Dr. P. Dorman	Assigned Registrar:	Damian Holliman

brains

Last updated 19 Jan 2009
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