CORTICOSTEROID RANDOMISATION AFTER SIGNIFICANT HEAD INJURY

Not Applicable

• Conditions: -F078 Other organic personality and behavioural disorders due to brain disease, damage and dysfunction; Other organic personality and behavioural disorders due to brain disease, damage and dysfunction; F078

• Registration Number: PER-095-03
• Lead Sponsor: ONDON SCHOOL OF HYGIENE & TROPICAL MEDICINE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-01-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All patients 16 years of age and older are eligible, with cranial trauma in which, in the absence of sedation, they obtain a score of 14 or less in the first 8 hours of the trauma. Although it is allowed to admit patients up to a maximum of 8 hours post-trauma.

Exclusion Criteria

The routine exclusion of patients with gastrointestinal disorders or pregnancy is unnecessary, unless the responsible physician considers that there is a definitive contraindication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:• Death from any cause within the first two weeks of trauma<br>• Death or dependence six months after the trauma.<br>Measure:Effects of corticosteroids on mortality or disability secondary to major acute cranial trauma.<br>Timepoints:week two<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:not contemplated<br>Measure:not contemplated<br>Timepoints:not contemplated<br>