E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
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. |
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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 pulmonary emphysema and pneumothorax (barotrauma), pulmonary haemorrhage, radiographic and/or bacteriological verified nosocomial infections of the lung and ARDS according to AECC. LIS (lung injury score) Re-intubation due to other reasons (e. g. organic psycho syndrome (OPS), new aspiration, etc.) which are not related to the original lung contusion. Change in chest X-ray at baseline, 24 hours after treatment and discharge from ICU Mortality rate Total time and percentage of concentration of O2 after extubation Spirometry at discharge from ICU and/or from hospital (optional)
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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 ≤ 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.
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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 with PEEP > 12 mbar during stabilisation on ICU - 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 several minutes prior 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. - 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.)
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of duration of intubation (days) in the treated group compared to the control group . The achieved extubation must be maintained for at least 48 hours (succesful extubation). Non-invasive ventilation support can be accepted and must be documented.
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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 | 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 | Information not present in EudraCT |
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 | Yes |
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 |
standard of care treated control group |
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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 | 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 | 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
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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 | 12 |
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 | 12 |