E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute bleeding while undergoing aortic replacement 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 | 10061651 |
E.1.2 | Term | Aortic surgery |
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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 |
To determine if Haemocomplettan® P effectively reduces the amount of allogeneic blood products needed in patients experiencing acute bleeding during aortic-replacement surgery |
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E.2.2 | Secondary objectives of the trial |
To determine if Haemocomplettan® P is safe and well-tolerated in patients experiencing acute bleeding during aortic-replacement surgery |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Eighteen years of age or older · Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacment surgery (TAA) · Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures · Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery - Clinically relevant bleeding (microvasculature) defined as a 5-minute bleeding mass of 60 to 250 g AND - Intraoperative conditions prior to administration of study medication are ─ Body temperature > 36°C ─ Blood pH > 7.3 ─ Hb > 8.5 g/dL ─ ACT < 150 seconds
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E.4 | Principal exclusion criteria |
· Positive pregnancy test, pregnancy or lactation · Women of child-bearing age not using a medically approved method of contraception during the study · Previous aortic replacement at the same aortic site (redo surgery) · Undergoing an emergency operation · Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease) · Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery · ASA administration in the 3 days preceding study surgery, and a pathological (<74.5 U) ASPI Multiplate® test immediately preceding surgery begin · Clopidogrel administration in the 5 days preceding study surgery, and a pathological (<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin · Tirofiban administration in the 2 days preceding study surgery, and a pathological (<94.1 U) TRAP Multiplate® test immediately preceding surgery begin · Phenprocoumon administration in the 5 days preceding study surgery, and an INR > 1.28 immediately preceding surgery begin · Participation in another clinical study in the 4 weeks preceding aortic replacement · Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication · Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude) · Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given · Multiple morbidities, with a notably constrained remaining length of life. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects, between administration of study medication and 24 hours thereafter |
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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 | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 22 |
E.8.9.1 | In the Member State concerned days | 0 |