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


ABSTRACT: 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)?

SUBMITTER: Darsaut TE 

PROVIDER: S-EPMC4632683 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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

Darsaut Tim E TE   Magro Elsa E   Gentric Jean-Christophe JC   Batista André Lima AL   Chaalala Chiraz C   Roberge David D   Bojanowski Michel W MW   Weill Alain A   Roy Daniel D   Raymond Jean J  

Trials 20151104


<h4>Background</h4>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  ...[more]

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