Study documents

Study protocol and synopsis

Study protocol (version 1.8) and study protocol synopsis (version 1.8)

BMJ Open TRAUMOX2 protocol article and PDF (Open Access)

Protocol for biomarkers of oxidative stress (local Copenhagen sub-study (Danish); version 1.1)

Protocols for long-term outcomes

Protocol for 1-year mortality and functional outcome (version 1.0)

Protocol for health-related quality of life after 6 and 12 months (version 1.0)

Protocol for functional outcome in traumatic brain injury patients (version 1.0)

Statistical analysis plan (SAP)

Acta Anaesthesiologica Scandinavica TRAUMOX2 statistical analysis plan (SAP) and PDF (Open Access)

Statistical analysis plan for the biomarkers of oxidative stress sub-study version 1.0

Data Monitoring and Safety Committee

Charter for the independent Data Monitoring and Safety Committee (version 1.1)

Case Report Form (CRF)

eCRF in REDCap (for Danish sites)

eCRF in REDCap for biomarkers of oxidative stress (local Copenhagen sub-study; in Danish)

eCRF in REDCap (for sites outside of Denmark)

Example of the 8 hour oxygen interventions

Example of the data collection sheet (version 1.0) during the 8 hour oxygen intervention

Approvals

The Danish Research Ethics Committee (H-21018062)

The Danish Medicines Agency

EudraCT (2021-000556-19)

Knowledge Center on Data Protection (in the Capital Region of Denmark)

Collaboration agreement

Collaboration agreement between sponsor and trial site (template)

Trial participants

Trial information to the study guardian (Danish; version 1.1)

Trial information to the trial participant’s next-of-kin (Danish; version 1.3)

Trial information to the trial participant (Danish; version 1.2)

Proxy consent form by the 1st study guardian before inclusion (Danish; version 1.0)

Proxy consent form by the 2nd study guardian after inclusion (Danish; version 1.0)

Proxy consent form by the trial participant’s next-of-kin (Danish; version 1.1)

Informed consent form by the trial participant (Danish; version 1.1)

 

Trial information to the trial participant’s next of kin in the biomarker study of oxidative stress (local Copenhagen sub-study; Danish; version 1.1)

Trial information to the trial participant in the biomarker study of oxidative stress (local Copenhagen sub-study; Danish; version 1.1)

Proxy consent form by the trial participant’s next-of-kin in the biomarker study of oxidative stress (local Copenhagen sub-study; Danish; version 1.0)

Informed consent form by the trial participant in the biomarker study of oxidative stress (local Copenhagen sub-study; Danish; version 1.0)