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

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Brief Title

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?

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.
    


Study Type

Interventional


Primary Outcome

Mortality

Secondary Outcome

 Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation

Condition

Abdominal Aortic Aneurysm

Intervention

Open repair

Study Arms / Comparison Groups

 Open repair
Description:  Immediate Open Surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

613

Start Date

September 2009

Completion Date

July 21, 2016

Primary Completion Date

August 21, 2013

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.
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ray J. Ashleigh, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00746122

Organization ID

HTA07/37/64

Secondary IDs

ISRCTN48334791

Responsible Party

Sponsor

Study Sponsor

Imperial College London

Collaborators

 London School of Hygiene and Tropical Medicine

Study Sponsor

Ray J. Ashleigh, Principal Investigator, Manchester University NHS Foundation Trust


Verification Date

December 2019