Aortic & peripheral vascular disease
Methylprednisolone for acute type A aortic dissection patients undergoing total arch replacement: Design and rationale of the Medal trial
Study context
- Population
- Adults with acute type A aortic dissection awaiting emergency total aortic arch replacement with hypothermic circulatory arrest and selective cerebral perfusion; 9 large CV centresplanned
- Participants
- 340 adults
- Planned comparison
- Methylprednisolone 500 mg IV before cardiopulmonary bypass vs placebo
- Primary endpoint
- Postoperative major adverse outcome:
- All-cause death
- Postoperative neurological deficit
- KDIGO II–III AKI
- Respiratory syndrome [tracheal intubation >72 h, tracheostomy or re-intubation]
- Follow-up
- Until postoperative day 30 or discharge
Methodological detailsprospective, multicentre, double-blind, placebo-controlled, parallel-group, 1:1 randomisation, First subject enrolled June 24, 2022; results to be published after data collection and analysis
- Prospective
- Multicentre
- Double-blind
- Placebo-controlled
- Parallel-group
- 1:1 randomisation
- First subject enrolled June 24, 2022; results to be published after data collection and analysis
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Methylprednisolone for acute type A aortic dissection patients undergoing total arch replacement: Design and rationale of the Medal trial. Am Heart J. Published 11 October 2024. doi:10.
Summarised from the published abstract; every number is checked against it