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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49495
Enrollment
60
Registered
2017-04-07
Start date
2017-06-27
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

acquired brain injury Traumatic brain injury

Interventions

None listed

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026