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Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging with ‘Minimally-Invasive Segmental Artery Coil-Embolization’: A Randomized Controlled Multicentre Trial


Communication strategy

A plan will be delivered as to how communication with the public, e.g. with a web-site, press releases and newsletters will be put into effect. Policy makers and regulators are also a target audience and particular strategies for communication with them will also be described.

Project Data Management Plan

A project management handbook will be prepared which sets out the internal communication plan, meeting schedules and expectations of partners to support the described project management processes.

Ethical guidance document

A discussion of ethical questions ranging from the risk/benefit considerations of the coiling and waiting period after staging to dealing with incidental findings in CT/MRI scans will be presented in this report. The standpoint of the Trial Steering Committee, the ethics boards and the competent authorities will be presented.

Screening, Recruitment and Randomisation (1st 25 patients)

A report documenting the Screening, Recruitment and Randomisation will be submitted after the first 25 patients have been enroled in the trial

A report on the economic framework for the assessment of the two-stage procedure for aortic aneurysm repair

A list of the papers reviewed for developing the economic framework will be provided. The variables considered most relevant for the economic models will be listed and the questionnaires devloped here will be submitted. If a publication from this WP has already been accepted, it will be provided and may replace some of the aforementioned items.

Statistical Analysis Plan

A first draft of the Statistical Analysis Plan will be delivered. This document provides detailed information about the statistical analyses and models to be used for drawing inferences from the data.

PAPA-ARTiS Project Management Handbook

PAPA-ARTiS Project Management Handbook ‐ including programme of meetings, communication processes and roles and responsibilities of partners

Links with existing projects/professional bodies

A list of existing, planned and potential links with existing projects/professional bodies will be provided.

Clinical Trial Data Management plan

The Clinical Data Management Plan is a document that describes which clinical data will be acquired and how it will be handled, stored, checked for consistency and plausibility, cleaned, and made available for the final analysis. The document will also describe how the data will be preserved after end of the project, and possibly made available for further research.


Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging with ‘Minimally-Invasive Staged Segmental Artery Coil-Embolization’ (MIS²ACE): Trial protocol for a Randomized Controlled Multicentre Trial.

Author(s): David Petroff, Martin Czerny, Tilo Kölbel, Germano Melissano, Lars Lonn, Josephina Haunschild, Konstantin von Aspern, Petra Neuhaus, Johann Pelz, David Epstein, Nuria Romo-Avilés, Katja Piotrowski, Christian D Etz
Published in: BMJ Open, Issue Volume 9, Issue 3, 2019, ISSN 2044-6055
Publisher: BMJ Publishing Group

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