E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Asymptomatic abdominal aortic aneurysms |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000052 |
E.1.2 | Term | Abdominal aneurysm without mention of rupture |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000054 |
E.1.2 | Term | Abdominal aortic aneurysm |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002339 |
E.1.2 | Term | Aneurysm of aorta |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000051 |
E.1.2 | Term | Abdominal aneurysm |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002885 |
E.1.2 | Term | Aortic aneurysm repair |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066050 |
E.1.2 | Term | Aneurysm repair |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002882 |
E.1.2 | Term | Aortic aneurysm |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002338 |
E.1.2 | Term | Aneurysm of abdominal aorta |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Dæmpe det inflammatoriske respons efter EVAR med en enkelt præoperativ dosis methylprednisolon, for derved at mindske de postoperative gener. |
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E.2.2 | Secondary objectives of the trial |
At kortlægge det inflammatoriske respons forbundet med endovaskulær stentgraft behandling af aorta aneurismer (EVAR) – sammenhængen mellem mængden af muraltrombe, det postoperative inflammatoriske respons og forekomsten af senkomplikationer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Habile patienter der skal have foretaget elektiv EVAR af et asymptomatisk AAA
2. Alder >18 år
3. Informeret samtykke og fuldmagt
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | Primary end point(s) |
Som udtryk for postimplantationssyndromet bruges SIRS [9]– defineret som mindst to af nedenstående kriterier samtidig - indenfor de første 5 døgn:
temperatur > 38°C eller <36°C
Puls > 90/min
Respirationsfrekvens > 20/min eller PaCO2 <4,3 kPa
Leukocytter > 12,000/uL, < 4000 uL eller 10% umodne former
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Der kan ikke tænkes tilfælde hvor forsøgspersonen kan udelukkes fra projektet. Projektet i sin helhed kan afbrydes, hvis der uventet opstår alvorlige komplikationer til behandlingen.
Deltagerne kan når som helst trække sig ud af studiet.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |