Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS²ACE): trial protocol for a randomised controlled multicentre trial.
BMJ Open
; 9(3): e025488, 2019 03 04.
Article
em En
| MEDLINE
| ID: mdl-30837256
ABSTRACT
INTRODUCTION:
Spinal cord injury (SCI) including permanent paraplegia constitutes a common complication after repair of thoracoabdominal aortic aneurysms. The staged-repair concept promises to provide protection by inducing arteriogenesis so that the collateral network can provide a robust blood supply to the spinal cord after intervention. Minimally invasive staged segmental artery coil embolisation (MIS2ACE) has been proved recently to be a feasible enhanced approach to staged repair. METHODS ANDANALYSIS:
This randomised controlled trial uses a multicentre, multinational, parallel group design, where 500 patients will be randomised in a 11 ratio to standard aneurysm repair or to MIS2ACE in 1-3 sessions followed by repair. Before randomisation, physicians document whether open or endovascular repair is planned. The primary endpoint is successful aneurysm repair without substantial SCI 30 days after aneurysm repair. Secondary endpoints include any form of SCI, mortality (up to 1 year), length of stay in the intensive care unit, costs and quality-adjusted life years. A generalised linear mixed model will be used with the logit link function and randomisation arm, mode of repair (open or endovascular repair), the Crawford type and the European System for Cardiac Operative Risk Evaluation (euroSCORE) II as fixed effects and the centre as a random effect. Safety endpoints include kidney failure, respiratory failure and embolic events (also from debris). A qualitative study will explore patient perceptions. ETHICS AND DISSEMINATION This trial has been approved by the lead Ethics Committee from the University of Leipzig (435/17-ek) and will be reviewed by each of the Ethics Committees at the trial sites. A dedicated project is coordinating communication and dissemination of the trial. TRIAL REGISTRATION NUMBER NCT03434314.Palavras-chave
Texto completo:
1
Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Paraplegia
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Ensaios Clínicos Controlados Aleatórios como Assunto
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Estudos Multicêntricos como Assunto
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Aneurisma da Aorta Torácica
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Embolização Terapêutica
Tipo de estudo:
Clinical_trials
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Prognostic_studies
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Qualitative_research
Limite:
Adolescent
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Adult
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Aged
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Humans
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Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article