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| [ Print-friendly version ] |
| A Randomised trial of Unruptured Brain Arteriovenous malformations |
| ISRCTN | ISRCTN44013133 |
| ClinicalTrials.gov identifier | |
| Public title | A Randomised trial of Unruptured Brain Arteriovenous malformations |
| Scientific title | |
| Acronym | ARUBA |
| Serial number at source | 1 U01 NS051483-01A1 |
| Study hypothesis | The primary hypothesis of this trial is that medical management improves long-term outcomes of patients with unruptured Brain ArterioVenous Malformations (BAVM) compared to invasive therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination). |
| Ethics approval | This study has been approved by the Columbia University Medical Center Institutional Review Board (IRB# AAAB6286, approval date: 02/11/2005) |
| Study design | Randomised open parallel group international multicenter trial |
| Countries of recruitment | Australia, Brazil, Canada, Czech Republic, Finland, France, Germany, Italy, Lithuania, Portugal, Spain, Sweden, Switzerland, The Netherlands, UK, USA |
| Disease/condition/study domain | Adult patients with unruptured brain arteriovenous malformation |
| Participants - inclusion criteria |
1. Patient must have unruptured BAVM diagnosed by Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and/or angiogram
2. Patient must be 18 years of age or older 3. Patient must have signed informed consent |
| Participants - exclusion criteria |
1. Patient has BAVM presenting with evidence of recent or prior hemorrhage
2. Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy) 3. Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicts any invasive therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons) 4. Patient has baseline Rankin more than or equal to two 5. Patient has concomitant disease reducing life expectancy to less than ten years 6. Patient has thrombocytopenia (less than 100,000/nl) 7. Patient has coagulopathy (spontaneous or iatrogenic Inernational Normalised Ratio(INR) more than 1.5, Prothrombin Time (PT) more than 30) 8. Patient is pregnant, lactating, or plans to become pregnant 9. Patient has known allergy against iodine contrast agents 10. Patient has multiple-foci BAVMs 11. Patient has any form of arteriovenous or spinal fistulas 12. Patient has a diagnosed Vein of Galen type malformation 13. Patient has a diagnosed cavernous malformation 14. Patient has a diagnosed dural arteriovenous fistula 15. Patient has a diagnosed venous malformation 16. Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome 17. Patient has diagnosed BAVMs in context of moya-moya-type changes 18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber) |
| Anticipated start date | 01/08/2006 |
| Anticipated end date | 01/03/2014 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 800 |
| Interventions |
All patients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. Those allocated to the invasive treatment arm will also receive endovascular attempts at occlusion of the nidus and feeding vessels, compiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and
radiosurgery, these alone or in various combinations and timings. |
| Primary outcome measure(s) |
1. To determine whether medical management is superior to invasive therapy for preventing the composite outcome of death from any cause or stroke (hemorrhage or infarction confirmed by imaging) in the treatment of unruptured BAVMs
2. If medical management is not superior to invasive therapy, to determine whether medical management is not inferior to invasive therapy for preventing the composite outcome of death from any cause or stroke (hemorrhage or infarction confirmed by imaging) in the treatment of unruptured BAVMs |
| Secondary outcome measure(s) |
To determine whether treatment of unruptured BAVMs by medical
management decreases the risk of death or clinical impairment (Rankin Score more than or equal to two) at five years post-randomization compared to invasive therapy. |
| Sources of funding |
1. National Institutes of Health
2. National Institute of Neurological Disorders and Stroke(NINDS): 1 U01 NS051483-01A1 |
| Trial website | http://www.arubastudy.org |
| Publications |
Stapf C, Mohr JP, Choi JH, Hartmann A, Mast H.
Invasive treatment of unruptured brain arteriovenous malformations is experimental therapy. Curr Opin Neurol. 2006;19:63-68 |
| Contact name | Prof J. P. Mohr |
| Address |
Stroke Center / The Neurological Institute
Columbia University 710 West 168th Street |
| City/town | New York |
| Zip/Postcode | 10032 |
| Country | United States of America |
| Tel | +1 212 305 8033 |
| Fax | +1 212 305 5796 |
| jpm10@columbia.edu | |
| Sponsor | NIH - National Institute of Neurological Disorders and Stroke (USA) |
| Address |
c/o Claudia S. Moy
Neuroscience Center, Room 2214 6001 Executive Blvd., MSC9520 |
| City/town | Bethesda MD |
| Zip/Postcode | 20892-9520 |
| Country | United States of America |
| Sponsor website: | http://www.nih.gov/ |
| Date applied | 25/06/2006 |
| Last edited | 11/09/2006 |
| Date ISRCTN assigned | 11/09/2006 |
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