E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major surgery |
Chirurgia maggiore |
|
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 |
Heamodynamic stability after Tetraspan infusion |
Efficacia di ripristino volemico e pressorio nel periodo perioperatorio, attraverso valutazione clinica e laboratoristica |
|
E.2.2 | Secondary objectives of the trial |
Effect of Tetraspan on: Blood clotting Lactate Plasma electrolitis Acid_base equilibrium Renal function Haepatic function Blood losses Blood transfusion |
Effetto della somministrazione di Tetraspam e Sterofundin su: - Coagulazione del sangue (aPTT, PT, piastrine) - Morfologico - Lattato ematico - Elettroliti plasmatici e urinari (Na, K, Ca, Mg, Cl) - Equilibrio acido-base (emogasanalisi) - Funzione renale (creatininemia, diuresi) - Funzione epatica - Perdite ematiche - Trasfusione di sangue/emoderivati perioperatori |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children scheduled for major surgery, aged less than 36 months |
Pazienti programmati per chirurgia maggiore di eta' inferiore a 36 |
|
E.4 | Principal exclusion criteria |
Hiperhidratation Renal failure Intracranic haemorragy Epatic failure Cardiac failure |
o Stati di iperidratazione severa, incluso ledema polmonare o Insufficienza renale con oliguria o anuria o Sanguinamento intracranico o Severe ipersodiemia o ipercloremia o Ipersensibilita' e/o allergia verso lHES o gli eccipienti presenti nella formulazione di TetraspanO' 6%. o Insufficienza epatica o Insufficienza cardiaca congestizia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Arterial Pressure mainteinance |
Ripristino emodinamico |
|
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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
| |
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 | 0 |