E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who need thoracic aortic reconstruction surgery |
Patiënten die in aanmerking komen voor aorta reconstructie chirurgie |
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E.1.1.1 | Medical condition in easily understood language |
Patients who need aortic replacement surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
The primary objective of this study is, to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen after (ascending) aorta arc correction to an equivalent decrease in the number of allogeneic blood transfusions, compared to placebo? |
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E.2.2 | Secondary objectives of the trial |
Secondary objective: 1. Registration of blood loss postoperative 2. Registration of the number of re-operations related to persistent blood loss during the first 24 hours postoperatively. 3. Registration of the IC and admission time 4. Registration of hospital mortality. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•> 18 years • Competent • Scheduled for ascending aorta-arch replacement using HLM • Signed informed consent
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E.4 | Principal exclusion criteria |
• Presence thrombosis or previous myocardial infarction • Hypersensitivity to any component of FC • Congenital or acquired impaired clotting • hypofibrinogenemia (<1 g / l) • The use of vitamin K antagonists, direct thrombin inhibitors, antiplatelet or in the last 5 days before surgery • Previous cardiothoracic surgery |
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E.5 End points |
E.5.1 | Primary end point(s) |
Similar reduction in the number of allogenic blood transfusions to 24 hours post-operative after primary correction of the coagulation with a single dose of fibrinogen(4-8 grams) after ascending aorta-arch surgery with the use of CPB. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
There will be an interim analyses after 20 included subjects. After reaching our total number of subjects. After discharge of last patiënt there wil be evaluation. |
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E.5.2 | Secondary end point(s) |
• Post-operative blood loss of up to 24 hours after surgery (chest drain volume in ml) • reoperation for postoperative hospitalization • Admission time ICU (days) • Hospital stay (days) • Hospital Mortality |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After reaching our total number of subjects. After discharge of last patiënt there wil be evaluation. |
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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 | 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 | 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) | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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End of study is defined as discharge of the last subject |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |