POMEVAR : PreOperative Methylprednisolone in EndoVascular Aortic Repair- a randomized, double-blind, placebocontrolled trial. - POMEVAR

Conditions: Asymptomatic abdominal aortic aneurysms
MedDRA version: 14.0Level: LLTClassification code 10000052Term: Abdominal aneurysm without mention of ruptureSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0Level: LLTClassification code 10000054Term: Abdominal aortic aneurysmSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0Level: LLTClassification code 10002339Term: Aneurysm of aortaSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0Level: LLTClassification code 10000051Term: Abdominal aneurysmSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0Level: PTClassification code 10002885Term: Aortic aneurysm repairSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.0Level: PTClassification code 10066050Term: Aneurysm repairSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.0Level: PTClassification code 10002882Term: Aortic aneurysmSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0Level: LLTClassification code 10002338Term: Aneurysm of abdominal aortaSystem Organ Class: 10047065 - Vascular disorders

Registration Number: EUCTR2009-013441-28-DK

Lead Sponsor: Copenhagen University Hospital, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Habile patienter der skal have foretaget elektiv EVAR af et asymptomatisk AAA
2.Alder >18 år
3.Informeret samtykke og fuldmagt

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patienter med HIV, Hepatitis B+C
2.Immuninflammatorisk sygdom – undtagen lokalt behandlede hudlidelser og luftvejslidelser
3.Glaukom
4.Peptisk ulceration
5.Immunmodulerende behandling
6.Aktuel behandling for cancer.
7.Allergi overfor indholdsstoffer i Solu-Medrol
8.Alkoholforbrug: mænd >21 genstande og kvinder > 14 genstande ugentlig
9.Graviditet
10.ABI<70% (ankel-brachial indeks) – da det vil give anledning til IL-6 aktivitet
11.Patienter hvor follow-up ikke foregår på Rigshospitalet

Ad. 1.-9.: Baseret på anamnestiske oplysninger og tidligere journalnotater.
Ad. 5. og 6.: Herunder medtages peroral eller parenteral indtag af Glukokortikoider, Disease-modifying anti-rheumatic drugs, Cytostatika, Immunstimulerende midler, Immunosuppressiva og biologiske antireumatika (se Lægemiddel katalogets terapeutiske grupper).