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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47025

Enrollment

110

Registered

2015-07-08

Start date

2015-09-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Axonal Injury en Traumatic Brain Injury

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The clinical outcome measured by the Glasgow Outcome Scale- Extended (GOS-E) at 12 months is the primary outcome in this study.	—

Secondary

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

Countries

Netherlands

Outcome results