E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients needing multi-vessel treatment by coronary artery bypass graft (CABG) surgery |
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MedDRA Classification |
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 |
To compare the percent of patients with peak CK-MB elevations >/= 5 times the upper limit of normal after CABG surgery by CPB when administering HBOC-201 vs. standard of care treatment. |
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E.2.2 | Secondary objectives of the trial |
To measure safety and effectiveness |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Candidates for this study must meet ALL of the following criteria:
Subject is between the ages of 18 and 85. Subject is an acceptable candidate for CABG. Subject is scheduled for CABG (with or without planned valvular repair or replacement) by cardiopulmonary bypass. Subject signs informed consent Subject and the treating physician agree that subject can comply with all study procedures and follow-up visits at time of subject screening.
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E.4 | Principal exclusion criteria |
Candidates will be excluded from this study if ANY of the following criteria are present:
Pre-operative myocardial infarction, defined as CK level > 2 times upper limit of site normal 24 hours prior to CABG surgery. Renal failure defined as serum creatinine greater than 220 umol/L Subject has an ejection fraction ≤ 30% (as measured by Echocardiography within 30 days of study enrollment). Active infection. History of prior stroke within last six months or history of prior stroke with residual neurological deficit. Transient Ischemic attack within last 6 months. Subject has a history of coagulopathy. Subject is pregnant or currently breastfeeding. History of allergy to beef products. Pre-operative cardiogenic shock defined as cardiac index ≤ 1.8.mL/min/m2 despite the use of vassopressors. Underlying medical conditions that would limit subject’s life expectancy to less than 12 months. Severe pulmonary impairment (e.g., emphysema) that may interfere with weaning subject from ventilator. History of acute central nervous disorder (e.g., seizure or traumatic injury). Severe hypertension (160/90 mm Hg) that cannot be medically controlled despite treatment with two antihypertensive therapies. Severe liver dysfunction as defined by total bilirubin ≥ 51 umol/L or 2 times the site normal limit of AST or ALT activity. Subject has systemic mastocytosis. Subject has any condition that pre-disposes the subject to systemic mast cell degranulation or hypersensitivity reactions or a history of severe allergic reactions to drugs or environmental allergens. Subject has participated in another investigational drug, biologic or device study within 30 days prior to study enrollment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of peak CK-MB elevation ≥ 5 times the upper limit of normal, determined from serial measures of CK-MB testing at 6, 12 and 18 hours or longer post-procedure to determine peak CK-MB elevation. |
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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 | No |
E.6.4 | Safety | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 0 |
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 | 0 |