E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
adult patients affected by pulmonary contusion from chest trauma at risk of ALI/ARDS |
|
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 | 10061230 |
E.1.2 | Term | Lung injury |
|
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 evaluate the efficacy and safety of Curosurf Poractant Alfa, porcine surfactant administered by bronchoalveolar lavage BAL in terms of reduction of duration of intubation days , in adult patients with pulmonary contusion. |
|
E.2.2 | Secondary objectives of the trial |
Response rates under standard conditions PaO2/FiO2 ratio and Ventilation Index VI RRx PIP-PEEP xPaCO2/1000. Occurrence of complications as |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-The subject must be between 18 - 70 years of age -The subjects must have a diagnosis based on clinical signs and /or radiographic and CT scan evidence of uni- or bilateral lung contusion involving one or more lobes -Subject must be intubated and artificially ventilated -Subject must be at ICU and randomised to one of the study arms within 8804; 6 hours of trauma -Subject must be in a clinically stable condition with efficacious, stable ventilation support for one hour before BAL, which therefore must be performed after a maximum of 7 hours from trauma. -Evidence for date and time of the trauma must be available; the maximum admissible time uncertainty must not exceed 30 minutes. -Informed Consent |
|
E.4 | Principal exclusion criteria |
- Subjects with an anamnestically known hypersensitivity against surfactants - Subject is female with childbearing potential and a in such cases mandatory pregnancy test is positive - Subjects who have at least one other source of severe lung injury due to inhalation of toxic gases, burnings, acids or similar substances in addition to the lung contusion - Subjects who suffer from anamnestically known chronic lung disease COPD Stage III - Subjects who suffer from anamnestically known status asthmaticus - Subject with severe ventilation refractory hypoxemia paO2/FiO2 50 at PEEP 12 mbar - Subjects with congestive heart failure and/or uncorrected congenital heart disease - Subjects with cardiogenic pulmonary edema - Subjects who have their hemo- and/or pneumothorax not adequately resolved at time of randomisation - Subjects who need abdominal and/or lung surgery - Subjects with severe brain injury Glasgow Coma Scale 10 , need for neurosurgery, brain death - Terminal patients with an estimated life expectancy of less than 4 weeks - Subjects who are treated with another surfactant during the whole study period - Subject s demand for another experimental drug - Subject s demand for medications which could be dangerous for the patient according to their SPC - Subject s demand for non depolarizing muscle relaxants except during bronchoscopy - Subjects with presence of abdominal lesions which are known to create severe post-operative complications e.g. sepsis, delay in intestinal canalization, etc. - Subjects with a Body Mass Index BMI 30 23 . - Subject is anamnestically known for participation in other clinical studies or termination of other clinical trials within two months prior trauma. - Subjects with available evidence of legal restrictions for their ability to provide informed consent e.g. soldiers, prisoners, severe mental diseases, severe drug addiction etc. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of duration of intubation days by 30 for the treated group compared to the control group. Successful extubation is defined as no need for re-intubation within 48 hours. Non-invasive ventilation support can be accepted and must be documented. |
|
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 | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
terapia ventilatoria standard |
|
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |