Trauma Clinical Trial
— TRAUMOX2Official title:
Comparing Restrictive vs. Liberal Oxygen Strategies for Trauma Patients: The TRAUMOX2 Trial
Verified date | October 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. According to Advanced Trauma Life Support guidelines, all severely injured trauma patients should receive supplemental oxygen. The objective of TRAUMOX2 is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours following trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined primary endpoint).
Status | Active, not recruiting |
Enrollment | 1420 |
Est. completion date | June 1, 2024 |
Est. primary completion date | October 12, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged =18 years, including fertile women - Blunt or penetrating trauma mechanism - Direct transfer from the scene of accident to one of the participating trauma centers - Trauma team activation - The enrolling physician must initially expect a hospital length of stay for 24 hours or longer Exclusion Criteria: - Patients in cardiac arrest before or 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Rigshospitalet, Copenhagen University Hospital | Copenhagen | |
Denmark | Odense University Hospital | Odense | |
Netherlands | Erasmus MC, University Medical Center Rotterdam | Rotterdam | |
Switzerland | Inselspital University Hospital Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | The Novo Nordic Foundation |
Denmark, Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined primary endpoint) | The assessment of the major respiratory complications will be performed by at least two allocation blinded primary outcome assessors (specialists in anesthesiology, intensive care, emergency medicine or similar); blinding will be ensured by concealing all information indicative of the allocation prior to assessment | Day 30 after enrollment | |
Secondary | 30-day mortality | Assessed in the patient's medical record/register | Day 30 after enrollment | |
Secondary | 12-month mortality | Assessed in the patient's medical record/register | 12 months after enrollment | |
Secondary | Major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days | Data from the combined primary endpoint assessment | Day 30 after enrollment | |
Secondary | Hospital length of stay | Number of days | From date of admission to discharge from the hospital, up to 12 months after enrollment | |
Secondary | ICU length of stay | Number of days | From date of admission to discharge from the ICU, up to 12 months after enrollment | |
Secondary | Time on mechanical ventilation | Number of hours; only mechanical ventilation in the ICU should be considered | From initiation of mechanical ventilation to being ventilator-free within 30 days after enrollment | |
Secondary | Days alive outside the ICU | Number of days | ICU-free days within 30 days after enrollment | |
Secondary | Days alive without mechanical ventilation | Number of days; only mechanical ventilation in the ICU should be considered | Ventilator-free days within 30 days after enrollment | |
Secondary | Re-intubations | Number of re-intubations; only re-intubations in the ICU should be considered | Within 30 days after enrollment | |
Secondary | Pneumonia post-discharge | Number of trial participants; evaluated through medicines prescribed after hospital discharge in countries where this information is available | From discharge to a maximum of 30 days after enrollment | |
Secondary | Episode(s) of hypoxemia during intervention (saturation <90%) | Defined as number of times the valid oxygen saturation is below 90%; if it is below 90%, above 90% and below 90% again, then it should be registered as 2 episodes | During the 8 hours of the oxygen intervention arms | |
Secondary | Surgical site infections | Defined as per the Centers for Disease Control and Prevention (CDC) criteria for a surgical site infection event | Within 30 days after enrollment | |
Secondary | 5-level EQ-5D version (EQ-5D-5L) score | Conducted through a telephone interview where the patient is asked to indicate his/her health state
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) The EQ-5D descriptive system consists of a scale (minimum score = 5 and maximum score = 25) where the lowest score (5) indicates no problems whereas the highest score (25) indicates extreme problems The EQ VAS (visual analogue scale) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled "The worst health you can imagine" (minimum score = 0) and "The best health you can imagine' (maximum score = 100) |
6 and 12 months post-trauma | |
Secondary | The Glasgow Outcome Scale Extended (GOSE) score | Conducted through a telephone interview where the patient/patient's next-of-kin/caretaker is interviewed through a structured questionnaire to assess the functional recovery after trauma
The GOSE consists of a scale (minimum value = 1 and maximum value = 8); each patient given a score based on the interview: 1 = Death, 2 = Vegetative state, 3 = Lower severe disability, 4 = Upper severe disability, 5 = Lower moderate disability, 6 = Upper moderate disability, 7 = Lower good recovery, 8 = Upper good recovery |
6 and 12 months post-trauma | |
Secondary | Levels of oxidative stress biomarkers, primarily malondialdehyde (MDA) at hour 24 | The unit of the oxidative stress biomarker depends on the chosen analysis of the specific biomarker | Hour 0, hour 8, hour 24 and hour 48 after enrollment |
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