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

NCT ID: NCT00746122

Last Updated: 2019-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

613 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-07-21

Brief Summary

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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

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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.

Conditions

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Abdominal Aortic Aneurysm

Keywords

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open repair

Immediate Open Surgery

Group Type OTHER

Open repair

Intervention Type PROCEDURE

Standard treatment of emergency open surgery

Endovascular strategy

Endovascular strategy involves immediate computed tomography (CT) and emergency Endovascular aneurysm repair (EVAR), with open repair for patients anatomically unsuitable for EVAR

Group Type EXPERIMENTAL

EVAR

Intervention Type PROCEDURE

Emergency endovascular aneurysm repair

Interventions

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Open repair

Standard treatment of emergency open surgery

Intervention Type PROCEDURE

EVAR

Emergency endovascular aneurysm repair

Intervention Type PROCEDURE

Other Intervention Names

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open surgical repair open surgery Endovascular Aneurysm Repair (EVAR)

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ray J. Ashleigh

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Foundation Trust

Simon J. Howell, MRCP(UK) MSc MD

Role: PRINCIPAL_INVESTIGATOR

Leeds Teaching Hospitals NHS Trust

Ian Chetter, FRCS

Role: PRINCIPAL_INVESTIGATOR

Hull & East Yorkshire Hospitals NHS Trust

Shane MacSweeney, MA MB BChir MChir FRCSEng

Role: PRINCIPAL_INVESTIGATOR

Nottingham University Hospitals NHS Trust

Matthew J. Bown, MBChB MD FRCS (Gen Surg)

Role: PRINCIPAL_INVESTIGATOR

University Hospitals, Leicester

Jonathan R Boyle, FRCSEd MD FRCS(Gen)

Role: PRINCIPAL_INVESTIGATOR

Cambridge Vascular Unit, Addenbrooke's Hospital

Meryl Davis, FRCS

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hampstead NHS Trust

Matthew Thompson, FRCS

Role: PRINCIPAL_INVESTIGATOR

St George's Healthcare NHS Trust

Colin D Bicknell, FRCS

Role: PRINCIPAL_INVESTIGATOR

Imperial College NHS Trust

Dynesh Rittoo, MBChB FRCS

Role: PRINCIPAL_INVESTIGATOR

The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust

Jonathan Davies, FRCS FRCS(Ed)

Role: PRINCIPAL_INVESTIGATOR

Royal Cornwall Hospitals NHS Trust

Rachel Bell, FRCS

Role: PRINCIPAL_INVESTIGATOR

Guy's & St Thomas' Hospital

Mike G Wyatt, FRCS

Role: PRINCIPAL_INVESTIGATOR

The Newcastle upon Tyne Hospitals NHS Trust

Ferdinand Serracino-Inglott, FRCSI, FRCS

Role: PRINCIPAL_INVESTIGATOR

Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust

Paul Bachoo, MBChB FRCS MSc

Role: PRINCIPAL_INVESTIGATOR

Aberdeen Royal Infirmary

Woolagasen Pillay, FCS(SA)

Role: PRINCIPAL_INVESTIGATOR

Doncaster Royal Infirmary

Syed W Yusuf, FRCS

Role: PRINCIPAL_INVESTIGATOR

Royal Sussex County Hospital

Paul Walker

Role: PRINCIPAL_INVESTIGATOR

The James Cook University Hospital , South Tees Hospitals NHS Foundation Trust

Colin Nice

Role: PRINCIPAL_INVESTIGATOR

Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust

Andrew Gordon, FRCS

Role: PRINCIPAL_INVESTIGATOR

Cardiff and Vale University Health Board

Adam Howard, FRCS

Role: PRINCIPAL_INVESTIGATOR

Colchester General Hospital

Noel Wilson, FRCS MS

Role: PRINCIPAL_INVESTIGATOR

Kent and Canterbury Hospital

Domenico Valenti, PhD FRCS FEBVS

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

David McLain, MBBS, FRCS (Gen Surg), FEBVS

Role: PRINCIPAL_INVESTIGATOR

Aneurin Bevan Health Board

Patrick Chong, FRCS

Role: PRINCIPAL_INVESTIGATOR

Frimley Park Hospital NHS Foundation Trust

Raj Bhat,,FRCS(Ed),FRCR

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Luc Dubois, MSc

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre, University of Western Ontario, Canada

Simon Hobbs, MD, FRCS (Eng), BMedSc

Role: PRINCIPAL_INVESTIGATOR

The Royal Wolverhampton Hospitals NHS Trust

Stephen Cavanagh, MBChB, MD, FRCS(Gen)

Role: PRINCIPAL_INVESTIGATOR

York Teaching Hospital NHS Foundation Trust

Timothy Rowlands, FRCS (Eng)

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Derby and Burton NHS Foundation Trust

John Asquith, MRCP, FRCR

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Staffordshire

Locations

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London Health Sciences Centre, University of Western Ontario

London, Ontario, Canada

Site Status

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Site Status

University Hospital of Wales, Cardiff and Vale NHS Trust

Cardiff, South Glamorgan, United Kingdom

Site Status

The Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, West Midlands, United Kingdom

Site Status

Aberdeen Royal Infirmary, NHS Grampian

Aberdeen, , United Kingdom

Site Status

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status

Brighton and Sussex University Hospitals NHS Trust

Brighton, , United Kingdom

Site Status

Vascular Unit, Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Kent & Canterbury Hospital

Canterbury, , United Kingdom

Site Status

Colchester General Hospital

Colchester, , United Kingdom

Site Status

Royal Derby Hospital

Derby, , United Kingdom

Site Status

Doncaster and Bassetlaw Hospitals NHS Foundation Trust

Doncaster, , United Kingdom

Site Status

NHS Tayside

Dundee, , United Kingdom

Site Status

Frimley Park Hospital NHS Foundation Trust

Frimley, , United Kingdom

Site Status

Queen Elizabeth Hospital

Gateshead, , United Kingdom

Site Status

Hull Royal Infirmary

Hull, , United Kingdom

Site Status

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, , United Kingdom

Site Status

Royal Free Hampstead NHS Trust

London, , United Kingdom

Site Status

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

St George's Hospital, St George's Healthcare NHS Trust

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust

Manchester, , United Kingdom

Site Status

University Hospital of South Manchester

Manchester, , United Kingdom

Site Status

The James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, , United Kingdom

Site Status

Royal Gwent Hospital

Newport, , United Kingdom

Site Status

Queen's Medical Centre

Nottingham, , United Kingdom

Site Status

The York Hospital

York, , United Kingdom

Site Status

Countries

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Canada United Kingdom

References

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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.

Reference Type RESULT
PMID: 24418950 (View on PubMed)

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.

Reference Type RESULT
PMID: 25855369 (View on PubMed)

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.

Reference Type RESULT
PMID: 26104471 (View on PubMed)

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.

Reference Type RESULT
PMID: 29138135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29860967 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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https://improvetrial.org/

Improve trial website

Other Identifiers

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ISRCTN48334791

Identifier Type: REGISTRY

Identifier Source: secondary_id

HTA07/37/64

Identifier Type: -

Identifier Source: org_study_id