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Neurotraumatology Quality Registry


- candidate number24707
- NTR NumberNTR6003
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jul-2016
- Secondary IDsPS2014-06 Hersenstichting
- Public TitleNeurotraumatology Quality Registry
- Scientific TitleComparative effectiveness research within a Dutch Neurotraumatology Quality Registry
- ACRONYMNet-QuRe
- hypothesisBased on a new Neurotraumatology Quality Registry, best practices can be identified in the health care chain for patients with moderate and severe TBI
- Healt Condition(s) or Problem(s) studiedTraumatic brain injury
- Inclusion criteria- Diagnosis of Traumatic Brain Injury
- GCS score =< 8 or GCS score > 8 in combination with (intra)cranial deficits on first or second CT scan
- Presentation at ER within 24 hours
- Age >= 16 years
- Exclusion criteria- Insufficient mastering of the Dutch or English language
- Serious (neurological) morbidity pre-injury which may interfere with TBI outcome
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate1-jan-2020
- Target number of participants1000
- InterventionsNA
- Primary outcomeGlasgow Outcome Scale Extended Health-related Quality of Life
- Secondary outcomePhysical functioning, Cognitive functioning, Depression, Aphasia, Disease Awareness, Fatigue, Activities, Participation, Employment Outcome, Healthcare Consumption, Costs
- TimepointsHospital admission, Hospital discharge, Rehabilitation admission, Rehabilitation discharge, 6 months, 12 months, 24 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES MH Heijenbrok-Kal
- CONTACT for SCIENTIFIC QUERIES MH Heijenbrok-Kal
- Sponsor/Initiator Rijndam revalidatiecentrum Rotterdam, the Netherlands, Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Hersenstichting Nederland
- Publications
- Brief summaryMany acute and post-acute interventions for traumatic brain injury (TBI) are not evidence-based. Clinical practice is often too complex to be studied in clinical trials. Strict in- and exclusion criteria and selected treatment settings result in limited external validity. Large between-institution variation in process and structure of treatment may remain unnoticed leading to suboptimal patient outcomes. Comparative effectiveness research (CER) is a promising alternative to investigate the effectiveness of treatments in clinical practice. CER depends on high quality observational data, which are currently lacking in the Netherlands. Therefore development of a quality registry is a prerequisite to open the black box of the acute and post-acute treatment variety for TBI.
- Main changes (audit trail)
- RECORD28-jul-2016 - 29-sep-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl