@misc{10481/57531,
year = {2019},
url = {http://hdl.handle.net/10481/57531},
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 and analysis This randomised controlled trial
uses a multicentre, multinational, parallel group design,
where 500 patients will be randomised in a 1:1 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.},
organization = {This project has received funding from the European Union’s Horizon
2020 research and innovation programme under grant agreement 733203 and
from the German Research Foundation under grant number ET 127/2-1.},
publisher = {BMJ},
title = {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},
doi = {10.1136/ bmjopen-2018-025488},
author = {Petroff, David and Epstein, David Mark and Romo Avilés, María Nuria},
}