Multimodal brain monitoring in traumatic brain injury: A prospective observational cohort study

Recruiting

Conditions: acquired brain injury
Traumatic brain injury
10029305

Registration Number: NL-OMON49495

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Severe or moderate TBI (Glasgow Coma Scale of 3-12 measured at trauma site or the Emergency Department).
- Admission to the ICU.
- Age 18 years or older.

Exclusion Criteria

- Patients after cardiopulmonary resuscitation with suspected postanoxic encephalopathy.
- Earlier hospitalization for TBI or stroke without full neurological recovery.
- Any progressive brain illness, such as a brain tumour or neurodegenerative disease.
- A limited life expectancy (<6 months).
- High risk for the development of iodine contrast induced nephropathy (according to local protocol).
- Women who are (potentially) childbearing.
- Contrast allergy.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters are:<br /><br>- EEG measurements during the first seven days of ICU admission<br /><br>- TCD measurements, performed twice a day during the first week<br /><br>- ICP measurement (on indication)<br /><br>- CT brain scan at admission<br /><br>- CT brain perfusion scan at day 1 and day 7 (6-8)<br /><br><br /><br>The GOSE at 12 months (obtained by telephone), will be used as the primary<br /><br>outcome parameter.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are:<br /><br>- Basic trauma and clinical data, including: age, sex, injury characteristics,<br /><br>initial GCS, GCS during ICU admission, pupillary abnormalities, pre-injury<br /><br>morbidity, haemodynamics, use of vasopressors (cumulative dose), saturation and<br /><br>glucose levels.<br /><br>- CT and MRI data obtained for routine clinical practise<br /><br><br /><br>Secondary outcome parameters are:<br /><br>- neurological outcome evaluated by the GOSE at hospital discharge and 6<br /><br>months.</p><br>