Clinical trial NCT00746122: Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
Official title: Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurysm?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: University of Cambridge
name: The Leeds Teaching Hospitals NHS Trust
name: St George's, University of London
First posted: 2008-09-03
Enrollment: 613
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 30 days, 1-year and 3-years from randomisation
Secondary outcomes:
measure: Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation
timeFrame: 3-years from randomisation
measure: Hospital Costs to Enable Cost-effectiveness Evaluation
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University of Western Ontario
state: Ontario
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Cardiff and Vale NHS Trust
state: South Glamorgan
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospitals NHS Trust
state: West Midlands
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary, NHS Grampian
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
city: Cambridge
country: United Kingdom
facility: Vascular Unit, Addenbrooke's Hospital
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital NHS Foundation Trust
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Royal Free Hampstead NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's Hospital, St George's Healthcare NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: York
country: United Kingdom
facility: The York Hospital
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Ray J. Ashleigh
role: PRINCIPAL_INVESTIGATOR
affiliation: Leeds Teaching Hospitals NHS Trust
name: Simon J. Howell, MRCP(UK) MSc MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hull & East Yorkshire Hospitals NHS Trust
name: Ian Chetter, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Nottingham University Hospitals NHS Trust
name: Shane MacSweeney, MA MB BChir MChir FRCSEng
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals, Leicester
name: Matthew J. Bown, MBChB MD FRCS (Gen Surg)
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge Vascular Unit, Addenbrooke's Hospital
name: Jonathan R Boyle, FRCSEd MD FRCS(Gen)
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Free Hampstead NHS Trust
name: Meryl Davis, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: St George's Healthcare NHS Trust
name: Matthew Thompson, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College NHS Trust
name: Colin D Bicknell, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
name: Dynesh Rittoo, MBChB FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Cornwall Hospitals NHS Trust
name: Jonathan Davies, FRCS FRCS(Ed)
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's & St Thomas' Hospital
name: Rachel Bell, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Newcastle upon Tyne Hospitals NHS Trust
name: Mike G Wyatt, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
name: Ferdinand Serracino-Inglott, FRCSI, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Aberdeen Royal Infirmary
name: Paul Bachoo, MBChB FRCS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Doncaster Royal Infirmary
name: Woolagasen Pillay, FCS(SA)
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Sussex County Hospital
name: Syed W Yusuf, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: The James Cook University Hospital , South Tees Hospitals NHS Foundation Trust
name: Paul Walker
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust
name: Colin Nice
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff and Vale University Health Board
name: Andrew Gordon, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Colchester General Hospital
name: Adam Howard, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Kent and Canterbury Hospital
name: Noel Wilson, FRCS MS
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College Hospital NHS Trust
name: Domenico Valenti, PhD FRCS FEBVS
role: PRINCIPAL_INVESTIGATOR
affiliation: Aneurin Bevan Health Board
name: David McLain, MBBS, FRCS (Gen Surg), FEBVS
role: PRINCIPAL_INVESTIGATOR
affiliation: Frimley Park Hospital NHS Foundation Trust
name: Patrick Chong, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Tayside
name: Raj Bhat,,FRCS(Ed),FRCR
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre, University of Western Ontario, Canada
name: Luc Dubois, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Wolverhampton Hospitals NHS Trust
name: Simon Hobbs, MD, FRCS (Eng), BMedSc
role: PRINCIPAL_INVESTIGATOR
affiliation: York Teaching Hospital NHS Foundation Trust
name: Stephen Cavanagh, MBChB, MD, FRCS(Gen)
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Timothy Rowlands, FRCS (Eng)
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Staffordshire
name: John Asquith, MRCP, FRCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: IMPROVE Trial Investigators; Powell JT, Sweeting MJ, Thompson MM, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve R, Heatley F, Hinchliffe RJ, Thompson SG, Ulug P. Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial. BMJ. 2014 Jan 13;348:f7661. doi: 10.1136/bmj.f7661.
citation: IMPROVE Trial Investigators. Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial. Eur Heart J. 2015 Aug 14;36(31):2061-2069. doi: 10.1093/eurheartj/ehv125. Epub 2015 Apr 7.
citation: Sweeting MJ, Balm R, Desgranges P, Ulug P, Powell JT; Ruptured Aneurysm Trialists. Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm. Br J Surg. 2015 Sep;102(10):1229-39. doi: 10.1002/bjs.9852. Epub 2015 Jun 24.
citation: IMPROVE Trial Investigators. Comparative clinical effectiveness and cost effectiveness of endovascular strategy v open repair for ruptured abdominal aortic aneurysm: three year results of the IMPROVE randomised trial. BMJ. 2017 Nov 14;359:j4859. doi: 10.1136/bmj.j4859.
citation: Ulug P, Hinchliffe RJ, Sweeting MJ, Gomes M, Thompson MT, Thompson SG, Grieve RJ, Ashleigh R, Greenhalgh RM, Powell JT. Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT. Health Technol Assess. 2018 May;22(31):1-122. doi: 10.3310/hta22310.