E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with non traumatic subarachnoid hemorrhage (WFNS = 3 -5) |
Pazienti affetti da emorragia subaracnoidea non traumatica di grado elevato (coma) |
|
E.1.1.1 | Medical condition in easily understood language |
Patients who suffer of diffuse and spontaneous intracranial hemorrhage ussaly due to arterial malformation rupture |
soggetti affetti da sanguinamento diffuso e spontaneo di solito correlato alla rottura di una malformazione di una arteria |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
E.1.2 | Term | Nervous system disorders |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 aim of the study is to assest the efficacy of inhalatory anestetic as cerebral vasodilatatory in prevention of vasospasm. This complication occurs in 25% of patients affected by subarachnoid hemorrhage. the assessment of perfusion CT allows the ipoperfused area detection, verifing the efficacy of isoflurane's vasodilatatory effect. |
Lo scopo di questo studio è valutare l'efficacia dell'anestetico inalatorio come vasodilatatore cerebrale nella prevenzione del vasospasmo, complicanza che si instaura in circa il 25% dei pazienti affetti da emorragia subaracnoidea grave. l'utilizzo della TAC perfusionale permette di identificare le aree realmente ipoperfuse e di verificare che l'uso dell'isoflurano si traduca in un reale recupero di flusso. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the safety of isoflurane during its vasodilatatory effect on cerebral blood volume and sistemic perfusion. |
valutare la sicurezza dell'anestetico inalatorio sul volume ematico cerebrale e sull'emodinamica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 18 years old Diagnosis of non-traumatic SAH Neurological and/or systemic presentation that requires support of vital functions and sedation. ICP monitoring Patients with vasospasm Acceptance of informed consent. |
Età > 18 anni Diagnosi di ESA non traumatica Stato di coma o insufficienze di organo che richiedano supporto delle funzioni vitali, con necessità di una sedazione che inficia il monitoraggio neurologico. monitoraggio della pressione intracranica (PIC) Pazienti con diagnosi di vasospasmo Acquisizione del consenso informato |
|
E.4 | Principal exclusion criteria |
Previous documented outcomes of cerebrovascular disease Patients with acute heart failure related to ESA State of pregnancy Patients with CLCR < 30 mL/min |
Esiti documentati di patologie cerebrovascolari Pazienti con insufficienza cardiaca acuta correlata ad ESA Stato di gravidanza Pazienti con ClCr < 30 mL/min |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of subjects who had a flow recondition at the second CT at least 50% of the best value detected in the first perfusion CT scan. |
La percentuale di soggetti che hanno avuto un ripristino del flusso alla seconda TC ad almeno il 50% del miglior valore rilevato nella prima scansione di TC perfusionale. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Changes in intracranial pressure during isoflurane delivery Changes in blood pressure during isoflurane delivery |
Variazioni di pressione endocranica in corso di erogazione di isoflurano. Variazioni di pressione arteriosa in corso di erogazione di isoflurano. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
PROSPETTICO INTERVENTISTICO FARMACOLOGICO MONOCENTRICO |
prospective, pharmacological, non-randomized, monocentric |
|
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
The study will be interrupted in the event of 3 interruptions of the experimental procedure before reaching the sample size set of 10 patients. The study will be considered concluded apun completation of the 10th case, as determined in the paragraph "sample size". |
Lo studio verrà interrotto nel caso si verificassero 3 interruzioni della somministrazione prima del raggiungimento della numerosità campionaria fissata a 10 pazienti. Lo studio sarà considerato concluso al completamento del 10° caso, come determinato nel paragrafo “Dimensione Campionaria”. |
|
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 | 24 |
E.8.9.1 | In the Member State concerned days | 73 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 73 |