E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
60 patients undergoing coronary artery bypass surgery |
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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 | 10011077 |
E.1.2 | Term | Coronary artery bypass |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To confirm safety and efficacy of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing coronary artery bypass grafting (CABG).
Primary effect variables is efficacy of fibrinogen infusion on number of transfusions with blood products during hospital stay.
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E.2.2 | Secondary objectives of the trial |
Secondary effects variables are effects of fibrinogen on bleeding volume after surgery, postoperative haemoglobin levels 12 and 24 h after surgery, pharmacoecomic effects, and effects of fibrinogen infusions on laboratory variables assessing global hemostasis, coagulation, fibrinolysis and platelet function.
Primary safety variables safety and tolerability as assessed by clinically detectable adverse events during hospital stay. Further on, overall safety and tolerability variables such as adverse events, vital signs (BP, HR, ECG), haematology, biochemistry, and urine analysis will also be evaluated.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males and females; age 18 years and above • Patients eligible for a first-time coronary artery bypass graft (CABG) surgery with a preoperative fibrinogen plasma concentration < 3.7 g/L. • Signed informed consent to participate in the study
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E.4 | Principal exclusion criteria |
• Patients undergoing reoperation • Clinical or laboratory signs of known bleeding disorder, • Clinical or laboratory signs of significant liver disease, or other significant disease or condition which in the investigators judgment may interfere with hemostasis • Any medication with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel och warfarin are withdrawn at least five days before surgery. Heparin and low-molecular heparin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication. • Administration of other investigational drugs within eight weeks preceding the pre-entry examination • Pregnant or lactating women
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary effect variables is efficacy of fibrinogen infusion on number of transfusions with blood products during hospital stay. |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | 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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |