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Immediate Management of the Patient With Aneurysm Rupture : Open Versus Endovascular Repair (IMPROVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
University of Cambridge
The Leeds Teaching Hospitals NHS Trust
St George's, University of London
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00746122
First received: September 1, 2008
Last updated: February 12, 2014
Last verified: February 2014

September 1, 2008
February 12, 2014
September 2009
July 2013   (final data collection date for primary outcome measure)
Can a strategy of preferential endovascular repair of ruptured abdominal aortic aneurysm, versus the current practice of open surgical repair, significantly reduce the 30 day mortality of ruptured abdominal aortic aneurysm? [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00746122 on ClinicalTrials.gov Archive Site
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Immediate Management of the Patient With Aneurysm Rupture : Open Versus Endovascular Repair
Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurism?

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 (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 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%). We also shall measure mortality (in-hospital, one year), costs, quality of life and cost-effectiveness as other key outcomes: all are expected to improve with endovascular repair.

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
  • Procedure: Open repair
    Immediate open surgery
  • Procedure: EVAR
    Endovascular Aneurysm Repair
    Other Name: CT scan
  • 1
    Immediate Open Surgery
    Intervention: Procedure: Open repair
  • Experimental: 2
    CT and endovascular repair if possible
    Intervention: Procedure: EVAR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
613
July 2016
July 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom
 
NCT00746122
HTA07/37/64
Yes
Imperial College London
Imperial College London
  • London School of Hygiene and Tropical Medicine
  • University of Cambridge
  • The Leeds Teaching Hospitals NHS Trust
  • St George's, University of London
Principal Investigator: Ray J. Ashleigh University Hospital of South Manchester NHS Foundation Trust
Principal Investigator: Simon J. Howell, MA FRCA MRCP(UK) MSc MD Leeds Teaching Hospitals NHS Trust
Principal Investigator: Ian Chetter, MB ChB FRCS Hull & East Yorkshire Hospitals NHS Trust
Principal Investigator: Shane MacSweeney, MA MB BChir MChir FRCSEng Nottingham University Hospitals NHS Trust
Principal Investigator: Matthew J. Bown, MBChB MD FRCS (Gen Surg) University Hospitals, Leicester
Principal Investigator: Jonathan R Boyle, MBChB FRCSEd MD FRCS(Gen) Cambridge Vascular Unit, Addenbrooke's Hospital
Principal Investigator: Meryl Davis, BS, MBBS, FRCS Royal Free Hampstead NHS Trust
Principal Investigator: Matthew Thompson, MD, FRCS St George's Healthcare NHS Trust
Principal Investigator: Nicholas J Cheshire, MB ChB FRCS(Gen) MD Imperial College NHS Trust
Principal Investigator: Dynesh Rittoo, MBChB FRCS The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Principal Investigator: Jonathan Davies, MBBS FRCS FRCS(Ed) Royal Cornwall Hospitals NHS Trust
Principal Investigator: Rachel Bell, MS FRCS Guy's & St Thomas' Hospital
Principal Investigator: Mike G Wyatt, MD, FRCS The Newcastle upon Tyne Hospitals NHS Trust
Principal Investigator: Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Principal Investigator: Paul Bachoo, MBChB FRCS MSc Aberdeen Royal Infirmary
Principal Investigator: Woolagasen Pillay, MBBch BSc FCS(SA) Doncaster Royal Infirmary
Principal Investigator: Syed Yusuf, MD MBBS DM FRCS Royal Sussex County Hospital
Principal Investigator: Paul Walker The James Cook University Hospital , South Tees Hospitals NHS Foundation Trust
Principal Investigator: Colin Nice Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust
Principal Investigator: Andrew Gordon, MBBS MRCP FRCS Cardiff and Vale University Health Board
Principal Investigator: Adam Howard, MBBS BMedSci FRCS Colchester General Hospital
Principal Investigator: Noel Wilson, MBBS FRCS MS Kent and Canterbury Hospital
Principal Investigator: Domenico Valenti, MD PhD FRCS FEBVS King's College Hospital NHS Trust
Principal Investigator: David McLain, MBBS, FRCS (Gen Surg), FEBVS Aneurin Bevan Health Board
Principal Investigator: Patrick Chong, MB BS FRCS Frimley Park Hospital NHS Foundation Trust
Principal Investigator: Raj Bhat, MS,FRCS(Ed),FRCR NHS Tayside
Principal Investigator: Thomas Forbes, MD, FRCSC, FACS London Health Sciences Centre, University of Western Ontario, Canada
Principal Investigator: Simon Hobbs, MBChB, MD, FRCS (Eng), BMedSc The Royal Wolverhampton Hospitals NHS Trust
Principal Investigator: Stephen Cavanagh, MBChB, MD, FRCS(Gen) York Teaching Hospital NHS Foundation Trust
Principal Investigator: Timothy Rowlands, MB ChB, FRCS (Eng) Derby Hospitals NHS Foundation Trust
Principal Investigator: John Asquith, MB ChB, MRCP, FRCR University Hospital of North Staffordshire
Imperial College London
February 2014

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