E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Abdominal Aortic Aneurysm |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049871 |
E.1.2 | Term | Abdominal aortic aneurysm haemorrhage |
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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 |
The aim of this pilot study is to investigate the acute effects of ascorbic acid supplementation on systemic and pulmonary endothelial function in the immediate post-operative period following AAA repair. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult patients admitted for elective open repair of AAA in the Royal Victoria Hospital, Belfast will be eligible for inclusion in the study. |
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E.4 | Principal exclusion criteria |
Exclusion criteria will be prior antioxidant therapy, known allergy to ascorbic acid or agents specified in the standardised anaesthetic protocol and lack of consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
As this is a phase II clinical study, several outcomes will be evaluated to determine whether treatment with ascorbic acid attenuates important surrogate physiological outcomes. The primary endpoint of this clinical study is to evaluate the efficacy of ascorbic acid to reduce endothelial dysfunction as measured by the change in plasma vWF at 4 hours following removal of the aortic cross-clamp. The following surrogate markers will also be assessed: 1) Systemic endothelial function as assessed by a) plasma adhesion molecules, ICAM, VCAM and E-selectin b) albumin creatinine ratio (ACR) c) Non-invasive assessment of the change in AIx in response to an endothelial dependent and endothelial independent vasodilator as described below. 2) Pulmonary endothelial function as assessed by the pulmonary dead space fraction. Exhaled breath condensate will be collected and its pH recorded, also the concentration of LTB4; a marker of pulmonary inflammation. In addition the PO2:FiO2 ratio will be recorded as a clinical indicator of pulmonary function when the dead space fraction is measured. 3) Oxidative stress as measured by a) serum lipid peroxides b) urinary F2 isoprostanes c) exhaled breath condensate concentration of hydrogen peroxide and myeloperoxidase. Although the incidence of intensive care admission, cardiac complications, length of hospital stay and survival will be recorded, these important clinical outcomes are not included as major outcome measures as the study is not adequately powered to assess these outcomes.
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |