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
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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. / Petroff, David; Czerny, Martin; Kölbel, Tilo; Melissano, Germano; Lonn, Lars; Haunschild, Josephina; von Aspern, Konstantin; Neuhaus, Petra; Pelz, Johann; Epstein, David Mark; Romo-Avilés, Nuria; Piotrowski, Katja; Etz, Christian D.
In: BMJ OPEN, Vol. 9, No. 3, 04.03.2019, p. e025488.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - 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
AU - Petroff, David
AU - Czerny, Martin
AU - Kölbel, Tilo
AU - Melissano, Germano
AU - Lonn, Lars
AU - Haunschild, Josephina
AU - von Aspern, Konstantin
AU - Neuhaus, Petra
AU - Pelz, Johann
AU - Epstein, David Mark
AU - Romo-Avilés, Nuria
AU - Piotrowski, Katja
AU - Etz, Christian D
N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/3/4
Y1 - 2019/3/4
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - Aged
KW - Aortic Aneurysm, Thoracic/therapy
KW - Embolization, Therapeutic/methods
KW - Endovascular Procedures/methods
KW - Humans
KW - Length of Stay
KW - Middle Aged
KW - Multicenter Studies as Topic/methods
KW - Paraplegia/prevention & control
KW - Patient Safety
KW - Patient Satisfaction
KW - Patient Selection
KW - Postoperative Complications/prevention & control
KW - Randomized Controlled Trials as Topic/methods
KW - Young Adult
U2 - 10.1136/bmjopen-2018-025488
DO - 10.1136/bmjopen-2018-025488
M3 - SCORING: Journal article
C2 - 30837256
VL - 9
SP - e025488
JO - BMJ OPEN
JF - BMJ OPEN
SN - 2044-6055
IS - 3
ER -
