Diffuse axonal injury in moderate to severe TBI patients: prognostic factors and impact on neural network integrity

Recruiting

• Conditions: Diffuse Axonal Injury en Traumatic Brain Injury; 10022114; 10042258

• Registration Number: NL-OMON47025
• Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

1) Glasgow Coma Scale Score of 3-12 after Traumatic Brain Injury, measured at trauma site or the Emergency Department
2) Diffuse Axonal Injury on MRI scan of the brain <5 months after trauma

Exclusion Criteria

1) patients with clinical history of dementia or mental retardation prior to trauma,
2) patients with mass lesions > 25cc on initial CT-scan of the brain (Marshall score 5 and
6),
3) earlier hospitalization for Traumatic Brain Injury,
4) addiction to alcohol or drugs,
5) unable to attend for follow-up.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The clinical outcome measured by the Glasgow Outcome Scale- Extended (GOS-E) at<br /><br>12 months is the primary outcome in this study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are<br /><br>* Health related Quality of Life (QOLIBRI) at 6 and 12 months<br /><br>* GOS-E at discharge, 6 and 12 months<br /><br>* IQCODE as filled out by a relative or other informant of the subject<br /><br>* CNS Vital Signs at 12 months<br /><br>* Anxiety and depression measured with HADS score at 12 months</p><br>