http://www.trialsjournal.com/content/16/1/497
1
Department of Surgery, Division of Neurosurgery, University of Alberta
Hospital, Mackenzie Health Sciences Center, Edmonton, AB, Canada
2 Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l’Université de Montréal (CHUM), Notre-Dame Hospital, Montreal, QC, Canada
3 Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest, France
4 Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), Notre-Dame Hospital, Interventional Neuroradiology (NRI), 1560 Sherbrooke East, Pavillion Simard, room Z12909, Montreal H2L 4 M1, QC, Canada
5 Service de Radiologie, CHU Cavale Blanche, Brest, EA 3878 GETBO, France
6 Department of Radio-Oncology, Centre Hospitalier de l’Université de Montréal (CHUM), Notre-Dame Hospital, Montreal, QC, Canada
2 Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l’Université de Montréal (CHUM), Notre-Dame Hospital, Montreal, QC, Canada
3 Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest, France
4 Department of Radiology, Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal (CHUM), Notre-Dame Hospital, Interventional Neuroradiology (NRI), 1560 Sherbrooke East, Pavillion Simard, room Z12909, Montreal H2L 4 M1, QC, Canada
5 Service de Radiologie, CHU Cavale Blanche, Brest, EA 3878 GETBO, France
6 Department of Radio-Oncology, Centre Hospitalier de l’Université de Montréal (CHUM), Notre-Dame Hospital, Montreal, QC, Canada
Trials 2015, 16:497
doi:10.1186/s13063-015-1019-0
The electronic version of this article is the complete one and can be found online at: http://www.trialsjournal.com/content/16/1/497
The electronic version of this article is the complete one and can be found online at: http://www.trialsjournal.com/content/16/1/497
Received: | 8 December 2014 |
Accepted: | 20 October 2015 |
Published: | 4 November 2015 |
© 2015 Darsaut et al.
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.
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.
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) < 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.
Trial status
TOBAS is currently recruiting patients in one Canadian center, and the protocol is
under ethics board review at other national and international sites. To date, 80 patients
have been recruited.
More at link.
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