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ISRCTN
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ISRCTN66212637
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ClinicalTrials.gov identifier
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Public title
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Acute endovascular treatment to improve outcome of ruptured aorto-iliac aneurysms
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Scientific title
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Acronym
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The AJAX trial
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Serial number at source
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NTR85; 2002B197
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Study hypothesis
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Acute endovascular treatment improves outcome of ruptured aorto-iliac aneurysms.
Please note that as of 19/10/2007 the anticipated end date of this trial was extended from 01/10/2007 to 01/08/2008.
As of 12/09/2008 the anticipated end date was again extended to 01/10/2010. At this time, the record was also updated to include an enlarged target number of participants. The previous target number of participants was 80.
Patient inclusion completed with 116 patients on 17/02/2011
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Lay summary
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Ethics approval
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Ethics approval received from the MEC of the Academic Medical Center in Amsterdam (certified MEC) on the 28th August 2003 (ref: MEC 03/161). A protocol amendment was approved on 26th November 2008.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Ruptured aorto-iliac aneurysms
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Participants - inclusion criteria
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1. Ruptured aneurysm (diagnosed by computed tomography [CT]-angiography)
2. Anatomical criteria:
2.1. Adequate infrarenal aortic neck
2.2. Adequate iliac anatomy
Added 12/01/2009:
3. Patients greater than 18 years male or female
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Participants - exclusion criteria
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1. Symptomatic aneurysm (no rupture)
2. Asymptomatic aneurysm
3. Juxtarenal aneurysm
4. Anatomical unsuitability
5. Patient unfit for open procedure
6. Extreme instability of the patient making CT-angiography impossible
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Anticipated start date
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05/04/2004
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Anticipated end date
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01/10/2010
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Status of trial
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Completed |
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Patient information material
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Patient information material can be found at: http://www.amc.nl/index.cfm?pid=1132 (in Dutch only)
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Target number of participants
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80 (this was amended on 12/01/2009 to 120 participants)
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Interventions
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CT angiography: all patients with suspected rupture of an abdominal aortic aneurysm will be examined by CT angiography to confirm the diagnosis of a ruptured aneurysm and to evaluate the anatomical suitability for endovascular treatment. The patient is entered in the study if the aneurysm is ruptured, the anatomical criteria for endovascular repair are fulfilled and the patient is fit for an open procedure. Patients will then be randomised for either open or endovascular treatment. If possible informed consent is obtained, if the clinical condition of the patient does not allow for a proper informed consent, informed consent will be asked after the patient has been treated (in accordance with Dutch Law: WMO §2, artikel 6-1).
Open procedure: patient under general anesthesia, laparotomy, standard aortic repair with either an aortic tube graft or a bifurcated graft, standard closure.
Endovascular procedure: Local anesthesia of both groin regions, dissection of the common femoral arteries, placement of aorto-uni-iliac endovascular graft through one of the femoral arteries and placement of an iliac occluder in the contralateral iliac artery, placement of a femoro-femoral cross-over bypass.
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Primary outcome measure(s)
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Mortality and severe morbidity, measured at 30 days, 3 months, 6 months.
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Secondary outcome measure(s)
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1. Quality of life, measured at 30 days, 3 months, 6 months
2. Length of intensive care stay, measured at 30 days, 3 months, 6 months
3. Cost-effectiveness, measured at 30 days, 3 months, 6 months
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Sources of funding
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Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2002B197)
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Trial website
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http://www.amc.nl/index.cfm?sid=324
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Publications
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1. Background, design, methods on http://www.ncbi.nlm.nih.gov/pubmed/16956484
2. Prospective cohort paper on http://www.ncbi.nlm.nih.gov/pubmed/17276096
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Contact name
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Dr
R
Balm
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Address
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Academic Medical Centre
Department of Vascular Surgery G4-111.1
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 5667832
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Fax
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+31 (0)20 5669243
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Email
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r.balm@amc.nl
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Sponsor
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Academic Medical Centre (AMC) (Netherlands)
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Address
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Department of Vascular Surgery
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl
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Date applied
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12/09/2005
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Last edited
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24/02/2011
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Date ISRCTN assigned
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12/09/2005
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