Summary of Trial
Where will the research take place?
In specialist hospital centres throughout the British Isles (and some centres in Europe), which have already attained sufficient experience in using endovascular repair for ruptured aneurysms and can offer a routine service.
What will happen to patients who join the trial?
Critically ill patients with a clinical diagnosis of ruptured aneurysm will be randomised, in the emergency room, to a strategy of endovascular repair if possible (endovascular first) or to current standard care (immediate transfer to the operating theatre for emergency open surgery): there is an equal chance of being offered each care pathway. Patients randomised to “endovascular first” will require a specialist radiological examination (CT scan) to assess anatomical suitability and plan for endovascular repair. This will cause a short delay before definitive repair can be commenced: the research will find out whether this delay is dangerous. Those patients not suitable for endovascular repair, after CT scan, will be taken for standard open surgery and the others will have endovascular repair.
What will we be assessing and measuring in trial patients?
The main outcome measure is survival within 30 days of surgery for ruptured aneurysm, which we hope will improve by 14% with the “endovascular first” strategy (from 47% to 33%). We also shall measure survival at hospital discharge and after 12 months, the costs of each treatment pathway, quality of life and cost-effectiveness. We hope that these will improve with endovascular repair.
Who belongs to the research team?
The research team includes specialists in clinical trials, health economics, statistics, pre-hospital & emergency care, interventional radiology, vascular & endovascular surgery, critical care, aneurysm research and a service user.
Who is supporting this research?
This research is supported by the National Institute for Health Research Health Technology Assessment programme and the trial is managed through Imperial College, London