Establishing ZIEL: ZNS - An interdisciplinary traumatic brain injury database for enhancing the evidence level of medical guidelines

Status:

completed 12/2017

Aims:

The project aims to improve the available evidence with regards to prognosis and therapy of traumatic brain injury (TBI) in multiple fields. Relevant confounders, such as disease modifying factors (DMFs) are suspected to worsen the outcome after TBI. However, DMFs have not been implemented in interdisciplinary guidelines for the treatment of TBI. The ZIEL-database will represent a synchronization and extension of existing institutions. The Network to be established and extended consist of the European study CENTER-TBI (Collaborative European NeuroTrauma Effectiveness Research in TBI) and the TraumaRegisterDGU® that is prevailingly active in Germany. This new study-group of sufficient size will enable a re-assessment of currently available but inconsistently applied therapeutic algorithms, relevant for clinical guidelines. In addition, the study will provide the basis for the development of new therapeutic strategies. Moreover, the ZIEL-database will serve for comparative investigation of clinically relevant DMFs after TBI, which are targets for prevention and treatment. Likewise, the quality of TBI specific care can be evaluated in a national as well as an international context.

Activities/Methods:

• Generation of a TBI add-on module associated to the TraumaRegisterDGU® and compatible with the CENTER-TBI study.
• Extension of the TBI add-on module addressing DMFs.
• Extraction and interim-analysis of datasets of the German CENTER-TBI participants.
• Retrospective analysis of the TraumaRegisterDGU® dataset 2013-2015 with focus on documented patients with TBI (AIS 1xxxx ≥ 3).
• Planning and development of a CENTER-TBI independent database, which can be continued -if applicable- after the end of recruitment into the CENTER-TBI study.
• Planning of annual study meetings.

Results:

The newly developed SHT-Dataset in the TraumaRegisterDGU® comprises 25 modules and is structured in analogy to the standard data set of the TraumaRegisterDGU®:

S. Basic data (5 additional modules, eg. pre-existing conditions),

A. Preclinical (1 additional module on initial neurological status),

B. Emergency room / surgery-phase (5 additional modules, e.g. CT and MRI diagnostics, neurosurgical interventions),

C. Intensive care unit (10 additional modules, e.g. unconsciousness and amnesia, drug therapies, inflammatory parameters)

D. Discharge (4 additional modules, e.g. pharmaceutical thrombosis prophylaxis and 1 additional module for the outcome survey at discharge and after 6 and 12 months).

The programming of the database was performed and could be completed by the end of the funding period. Final changes are planned after completion of the 2018 test phase at four participating clinics, before data collection for the pilot phase begins at the end of 2018 at 10-12 neurotrauma-centers. The analysis of the TraumaRegisterDGU® dataset between 2013-2015 revealed a total of 23.896 patients with moderate to severe TBI were treated in TR-DGU-affiliated hospitals in Germany (n = 567 hospitals) which corresponds to 7.965 cases/year with an incidence rate of 10,8/100.000/year. Isolated TBI was present in 39% of cases. The median patient age was 58 years, the male: female ratio was 2:1 and in 92,4% the trauma mechanism was blunt. Low falls were the most frequent cause of TBI (35,5%). 45,5% of the patients were intubated on-scene and received computed tomography (CT) imaging of the brain within median 18 minutes after hospital admission. In 13,9% of cases emergency neurosurgical intervention was performed. The overall mortality rate was 23,3%; the mortality for 100,000/inhabitants/year was 2,5. More than half of the patients had a good recovery with only minor disability while 14% survived with severe disability or in persistent vegetative state.

In the future, the BG hospitals and the patients treated there will benefit from the ZIEL-database in the sense of optimized treatment for the individual case ("precision medicine").

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