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Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial

BACKGROUND: The management of unruptured brain arteriovenous malformation (AVM) patients remains controversial. Furthermore, curative attempts to treat ruptured AVM patients have not been questioned so far, and there is a lack of prospective data on clinical results according to treatment modality....

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Autores principales: Darsaut, Tim E., Magro, Elsa, Gentric, Jean-Christophe, Batista, André Lima, Chaalala, Chiraz, Roberge, David, Bojanowski, Michel W., Weill, Alain, Roy, Daniel, Raymond, Jean
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632683/
https://www.ncbi.nlm.nih.gov/pubmed/26530856
http://dx.doi.org/10.1186/s13063-015-1019-0
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author Darsaut, Tim E.
Magro, Elsa
Gentric, Jean-Christophe
Batista, André Lima
Chaalala, Chiraz
Roberge, David
Bojanowski, Michel W.
Weill, Alain
Roy, Daniel
Raymond, Jean
author_facet Darsaut, Tim E.
Magro, Elsa
Gentric, Jean-Christophe
Batista, André Lima
Chaalala, Chiraz
Roberge, David
Bojanowski, Michel W.
Weill, Alain
Roy, Daniel
Raymond, Jean
author_sort Darsaut, Tim E.
collection PubMed
description BACKGROUND: The management of unruptured brain arteriovenous malformation (AVM) patients remains controversial. Furthermore, curative attempts to treat ruptured AVM patients have not been questioned so far, and there is a lack of prospective data on clinical results according to treatment modality. Endovascular treatment is often used aiming to improve the safety or efficacy of surgery or radiation therapy, but benefits have never been documented in a trial. A care trial context is needed to evaluate interventions at the same time they are practised. METHODS/TRIAL DESIGN: TOBAS is a pragmatic, prospective, multicenter, randomized, controlled trial and registry which offers a care trial context for brain AVM patients, including surgical resection, radiosurgery or endovascular embolization, alone or combined. The study includes two RCTs and a multimodality prospective registry. The objectives of the proposed study are to assess whether preventive interventions (surgery, embolization, radiation therapy, alone or combined), selected by the local treatment team and performed as locally practiced, randomly allocated and compared with conservative management, in unruptured brain AVM patients eligible for active or conservative management, can improve the proportion of patients having an independent outcome (modified Rankin Scale (mRS) < 3, as assessed by a standardized questionnaire administered by non-masked care personnel) at 10 years. All patients judged ineligible for randomized allocation are to be entered in a multimodal registry. The objective of a nested trial in patients with ruptured or unruptured AVMs to be treated by surgery or radiation therapy, is to assess whether pre-surgical or pre-radiation embolization, randomly allocated and compared with no embolization, can improve the proportion of patients with complete eradication of the AVM, as locally adjudicated, combined with a good clinical outcome (mRS < 3). The study will require up to 2000 patients in approximately 30 centers or more, followed for 10 years. TOBAS is registered at clinicaltrials.gov: NCT02098252 as of 25 March 2014. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-1019-0) contains supplementary material, which is available to authorized users.
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spelling pubmed-46326832015-11-05 Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial Darsaut, Tim E. Magro, Elsa Gentric, Jean-Christophe Batista, André Lima Chaalala, Chiraz Roberge, David Bojanowski, Michel W. Weill, Alain Roy, Daniel Raymond, Jean Trials Study Protocol BACKGROUND: The management of unruptured brain arteriovenous malformation (AVM) patients remains controversial. Furthermore, curative attempts to treat ruptured AVM patients have not been questioned so far, and there is a lack of prospective data on clinical results according to treatment modality. Endovascular treatment is often used aiming to improve the safety or efficacy of surgery or radiation therapy, but benefits have never been documented in a trial. A care trial context is needed to evaluate interventions at the same time they are practised. METHODS/TRIAL DESIGN: TOBAS is a pragmatic, prospective, multicenter, randomized, controlled trial and registry which offers a care trial context for brain AVM patients, including surgical resection, radiosurgery or endovascular embolization, alone or combined. The study includes two RCTs and a multimodality prospective registry. The objectives of the proposed study are to assess whether preventive interventions (surgery, embolization, radiation therapy, alone or combined), selected by the local treatment team and performed as locally practiced, randomly allocated and compared with conservative management, in unruptured brain AVM patients eligible for active or conservative management, can improve the proportion of patients having an independent outcome (modified Rankin Scale (mRS) < 3, as assessed by a standardized questionnaire administered by non-masked care personnel) at 10 years. All patients judged ineligible for randomized allocation are to be entered in a multimodal registry. The objective of a nested trial in patients with ruptured or unruptured AVMs to be treated by surgery or radiation therapy, is to assess whether pre-surgical or pre-radiation embolization, randomly allocated and compared with no embolization, can improve the proportion of patients with complete eradication of the AVM, as locally adjudicated, combined with a good clinical outcome (mRS < 3). The study will require up to 2000 patients in approximately 30 centers or more, followed for 10 years. TOBAS is registered at clinicaltrials.gov: NCT02098252 as of 25 March 2014. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-1019-0) contains supplementary material, which is available to authorized users. BioMed Central 2015-11-04 /pmc/articles/PMC4632683/ /pubmed/26530856 http://dx.doi.org/10.1186/s13063-015-1019-0 Text en © Darsaut et al. 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Darsaut, Tim E.
Magro, Elsa
Gentric, Jean-Christophe
Batista, André Lima
Chaalala, Chiraz
Roberge, David
Bojanowski, Michel W.
Weill, Alain
Roy, Daniel
Raymond, Jean
Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
title Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
title_full Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
title_fullStr Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
title_full_unstemmed Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
title_short Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
title_sort treatment of brain avms (tobas): study protocol for a pragmatic randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632683/
https://www.ncbi.nlm.nih.gov/pubmed/26530856
http://dx.doi.org/10.1186/s13063-015-1019-0
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