Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair

Not Applicable

Completed

Conditions: Abdominal Aortic Aneurysm

Interventions: Procedure: Open repair
Procedure: EVAR

Registration Number: NCT00746122

Lead Sponsor: Imperial College London

Brief Summary: The purpose of this trial is to assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm (AAA).

Detailed Description: Rupture of the main blood vessel of the body in the abdomen (ruptured abdominal aortic aneurysm) is fatal in over three-quarters of cases. In the past, those that survive have reached hospital alive and undergone emergency open surgery to repair the aneurysm and stop the bleeding: however, after this major emergency surgery only half the patients leave hospital alive. A newer, less-invasive method of aneurysm repair, endovascular repair, is based on repairing the aneurysm by inserting the repair graft up through one of the arteries in the groin. Endovascular repair has been tested in the elective situation and is associated with a 3-fold reduction in operative mortality versus the standard open surgery. Early work with selected patients has suggested that endovascular repair may be associated with up to a 2-fold reduction in operative mortality and more rapid recovery for ruptured abdominal aortic aneurysms. However, only 55-70% patients are anatomically suitable for endovascular repair.

Therefore, this research aims to determine whether a strategy of preferential emergency endovascular repair reduces both the mortality and cost of ruptured abdominal aortic aneurysm.

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). Patients randomised to "endovascular first" will require a specialist radiological examination (computed tomography, CT scan) to assess anatomical suitability and plan for endovascular repair. This will cause a short delay before definitive repair can be commenced. Those patients not suitable for endovascular repair, after CT scan, will be taken for standard open surgery. Patients will be randomised at 16-20 specialist centres in the United Kingdom (UK), who have already attained sufficient experience in using endovascular repair for ruptured aneurysms and can offer a routine service.

The primary outcome measure is 30-day operative mortality, which we hope will improve by 14% with the "endovascular first" strategy (from 47% to 33%). Secondary outcome measures include 24h, in-hospital and 1-year and 3-year mortality, re-interventions associated with the two treatment strategies as well as quality of life, costs and cost-effectiveness.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 613

Inclusion Criteria

Clinical suspicion of ruptured abdominal aortic aneurysm after review in Accident and Emergency (or other hospital unit).
Men and women over the age of 50 years will be recruited.

Exclusion Criteria

Patients with known connective tissue disorders (eg Marfan syndrome) where endovascular repair may not be beneficial.
Patients with known previous repair of an abdominal aortic aneurysm, because procedures either open or endovascular are likely to be very complex and there are no guidelines for anatomical restriction to repair.
Deeply unconscious and moribund patients since the chances of recovery are minimal.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open repair	Open repair	Immediate Open Surgery
Endovascular strategy	EVAR	Endovascular strategy involves immediate computed tomography (CT) and emergency Endovascular aneurysm repair (EVAR), with open repair for patients anatomically unsuitable for EVAR

Primary Outcome Measures

Name	Time	Method
Mortality	30 days, 1-year and 3-years from randomisation	Mortality, at 3 pre-specified time points

Secondary Outcome Measures

Name	Time	Method
Hospital Costs to Enable Cost-effectiveness Evaluation	3 years	Hospital costs to enable cost-effectiveness evaluation in Pounds (£)
Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation	3-years from randomisation	QALYs are a product of length of life and quality of life, since both of these are important to patients. Therefore, it is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life, and freedom from pain and mental disturbance.

Trial Locations

Locations (30): London Health Sciences Centre, University of Western Ontario
🇨🇦
London, Ontario, Canada
Aberdeen Royal Infirmary, NHS Grampian
🇬🇧
Aberdeen, United Kingdom
University Hospital of Wales, Cardiff and Vale NHS Trust
🇬🇧
Cardiff, South Glamorgan, United Kingdom
Royal Bournemouth Hospital
🇬🇧
Bournemouth, United Kingdom
Kent & Canterbury Hospital
🇬🇧
Canterbury, United Kingdom
Colchester General Hospital
🇬🇧
Colchester, United Kingdom
Royal Derby Hospital
🇬🇧
Derby, United Kingdom
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
🇬🇧
Doncaster, United Kingdom
NHS Tayside
🇬🇧
Dundee, United Kingdom
Frimley Park Hospital NHS Foundation Trust
🇬🇧
Frimley, United Kingdom
Hull Royal Infirmary
🇬🇧
Hull, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧
Leeds, United Kingdom
Royal Free Hampstead NHS Trust
🇬🇧
London, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧
London, United Kingdom
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
🇬🇧
Manchester, United Kingdom
The James Cook University Hospital
🇬🇧
Middlesbrough, United Kingdom
University Hospital of South Manchester
🇬🇧
Manchester, United Kingdom
The York Hospital
🇬🇧
York, United Kingdom
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧
Newcastle, United Kingdom
Royal Gwent Hospital
🇬🇧
Newport, United Kingdom
Queen's Medical Centre
🇬🇧
Nottingham, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust
🇬🇧
Wolverhampton, West Midlands, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
🇬🇧
Brighton, United Kingdom
Vascular Unit, Addenbrooke's Hospital
🇬🇧
Cambridge, United Kingdom
Queen Elizabeth Hospital
🇬🇧
Gateshead, United Kingdom
Leicester Royal Infirmary
🇬🇧
Leicester, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧
London, United Kingdom
St George's Hospital, St George's Healthcare NHS Trust
🇬🇧
London, United Kingdom
Royal Cornwall Hospital
🇬🇧
Truro, Cornwall, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧
London, United Kingdom