E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Victims of trauma are often healthy individuals prior to the incident, but acquire numerous complications including sepsis and pulmonary complications and diminished quality of life after trauma. We wish to optimize the oxygen treatment and look at the patients' 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days after being allocated to either an 8 hour liberal or restrictive oxygen strategy. |
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E.1.1.1 | Medical condition in easily understood language |
Trauma patients is a diverse group of patients with acute injuries, and we wish to optimize the oxygen treatment and assess the patients' 30 day mortality and major lung complications within 30 days. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033316 |
E.1.2 | Term | Oxygen saturation |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050322 |
E.1.2 | Term | Oxygen supplementation |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033323 |
E.1.2 | Term | Oxygen tension |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033324 |
E.1.2 | Term | Oxygen tension abnormal NOS |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033325 |
E.1.2 | Term | Oxygen tension decreased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033326 |
E.1.2 | Term | Oxygen tension increased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033327 |
E.1.2 | Term | Oxygen tension normal |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068430 |
E.1.2 | Term | Arterial oxygen saturation |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068431 |
E.1.2 | Term | Arterial oxygen saturation increased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068432 |
E.1.2 | Term | Arterial oxygen saturation decreased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068433 |
E.1.2 | Term | Arterial oxygen saturation abnormal |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068434 |
E.1.2 | Term | Arterial oxygen partial pressure increased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068435 |
E.1.2 | Term | Arterial oxygen partial pressure decreased |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068436 |
E.1.2 | Term | Arterial oxygen partial pressure abnormal |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
The objective of this trial, TRAUMOX2, will be to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours after trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined endpoint). |
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E.2.2 | Secondary objectives of the trial |
To assess mortality at 30 days and 12 months after trauma, major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days, hospital length of stay (HOS LOS), ICU length of stay (ICU LOS), days alive outside the ICU, time on mechanical ventilation (until 30 days), days alive without mechanical ventilation, number of re-intubations within 30 days, pneumonia post-discharge within 30 days, episodes with hypoxaemia during intervention (saturation <90%), surgical site infections within 30 days, EQ-5D-5L score and GOSE score at 6 months and 12 months post-trauma. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥18 years, including fertile women* - Blunt/penetrating trauma mechanism - Direct transfer from the scene of accident to one of the participating trauma centres - Trauma team activation - The enrolling physician must initially expect a hospital length of stay for 24 hours or longer
*There is no added risk for enrolment of fertile women as oxygen administration is approved for this group of patients |
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E.4 | Principal exclusion criteria |
- Patients in cardiac arrest before/on admission - Patients with a suspicion of carbon monoxide intoxication - Patients with no/minor injuries after secondary survey will be excluded if they are expected to be discharged <24 hours
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E.5 End points |
E.5.1 | Primary end point(s) |
The incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined endpoint). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after after trauma. |
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E.5.2 | Secondary end point(s) |
- Mortality at 30 days and 12 months after trauma - Major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days - Hospital length of stay, intensive care unit (ICU) length of stay and days alive outside the ICU - Time on mechanical ventilation (until 30 days), days alive without mechanical ventilation and re-intubation within 30 days - Pneumonia post-discharge within 30 days - Episodes of hypoxaemia during intervention (saturation <90%) - Surgical site infections within 30 days - EQ-5D-5L score at 6 and 12 months post-trauma - GOSE score at 6 months and 12 months post-trauma |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 days, 6 months and 12 months after trauma. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 |
Primary outcome assessors are treatment allocation blinded. See protocol for more blinding details. |
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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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Same drug in another dose |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |