Trial document




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  DRKS00014578

Trial Description

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Title

Assessment of the posttraumatic outcome of traumatic brain injury in older adults

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Demographic changes are a challenge in all fields of medicine. This is especially true for trauma surgery as the incidence of traumatic brain injuries (TBI) increase with growing aging populations. Older adults are more likely than younger people to sustain a traumatic brain injury leading to an increasing number of TBI-related hospitalizations and deaths in this population. Mild and moderate TBIs have wrongly been considered harmless for years, but there is a progressive understanding of its potential short- and long-term impacts. Increasing age has already been identified as an independent predictive factor for a worse functional outcome following a TBI. However, there is still little knowledge of the posttraumatic outcome in this population. Therefore the aim of this study is to evaluate the impact on daily life, quality of life, posttraumatic mobility and cognitive changes in older adults using defined outcome-criteria.

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Brief Summary in Scientific Language

Given the aging demographic, the incidence of falls and fall-related traumatic brain injuries (TBI) has been rising, particularly in older people. Accidental falls are the primary cause of traumatic brain injury resulting in TBI in more than 60% among the elderly [1, 2]. TBI is defined as any injury to the brain due to external forces and can be classified based on the severity by the Glasgow Coma Scale (GCS). Recent studies have shown that age is one of the strongest contributors to poor functional outcome after TBI. A severe TBI at the age of over 65 is associated with a significantly increased mortality rate [3, 4]. Meanwhile, it is becoming more clear that even mild and moderate TBIs without intracranial hemorrhage regularly lead to a posttraumatic disorder of consciousness, cognitive impairment and loss of function in geriatric patients [5, 6, 7]. There is also evidence that TBI increases the risk of neuropsychiatric symptoms. The prevalence of psychiatric disorders is reported to be 21-37% after sustained TBI in older adults [8, 9]. However, data on the influence of mild/moderate TBI in higher age are still rare.
The aim of this observational study is to investigate the posttraumatic outcome following a mild/moderate TBI in older individuals. Therefore, we intend to assess posttraumatic changes in life situation and quality of life and further evaluate patient’s cognition, affect, interpersonal relations, physical function and mood using standardized outcome parameters.

References:
1. Hodge AL, Sternlicht JP, Wagenhauser K et al (2003) Closed head injury in elderly and nonelderly patients. JAAPA 16:53–56.
2. Shandro JR, Spain DA, Dicker RA (2007) Recruitment strategies for a fall prevention program: if we build it, will they really come? J Trauma 63:142–146. doi: 10.1097/TA.0b013e318068428a
3. McIntyre A, Mehta S, Janzen S et al (2013) A meta-analysis of functional outcome among older adults with traumatic brain injury. NeuroRehabilitation 32:409–414. doi: 10.3233/NRE-130862
4. Mitra B, Cameron PA, Gabbe BJ et al (2008) Management and hospital outcome of the severely head injured elderly patient. ANZ J Surg 78:588–592. doi: 10.1111/j.1445-2197.2008.04579.x
5. Hukkelhoven CWPM, Steyerberg EW, Rampen AJJ et al (2003) Patient age and outcome following severe traumatic brain injury: an analysis of 5600 patients. J Neurosurg 99:666–673. doi: 10.3171/jns.2003.99.4.0666
6. Mushkudiani NA, Engel DC, Steyerberg EW et al (2007) Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. J Neurotrauma 24:259–269. doi: 10.1089/neu.2006.0028
7. Tokutomi T, Miyagi T, Ogawa T et al (2008) Age-associated increases in poor outcomes after traumatic brain injury: a report from the Japan Neurotrauma Data Bank. J Neurotrauma 25:1407–1414. doi: 10.1089/neu.2008.0577
8. Levin H, Goldstein F, MacKenzie E (1997) Depression as a Secondary Condition Following Mild and Moderate Traumatic Brain Injury. Semin Clin Neuropsychiatry 2:207–215. doi: 10.1053/SCNP00200207
9. Menzel JC (2008) Depression in the elderly after traumatic brain injury: a systematic review. Brain Inj 22:375–380. doi:

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Organizational Data

  •   DRKS00014578
  •   2018/04/24
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  •   yes
  •   Approved
  •   17-758, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   S06.0 -  Concussion
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Interventions/Observational Groups

  •   Patients, who have sustained a traumatic brain injury since 01/01/2014 and have been admitted to our emergency department are recruited. Outcome evaluation will be performed using a defined questionnaire.

    Inclusion criteria:
    i. Closed skull-brain trauma
    ii. Outpatient / inpatient treatment in our clinic
    iii. Age> 60 years, no maximum age
    iv. CCT imaging
    v. Sufficient language skills
    vi. Written informed consent
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome parameter that each study participant will answer when visiting our outpatient clinic for the study assessment is:

Community Integration Questionnaire

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Secondary Outcome

The following secondary outcome parameter will be investigated when patients visit our outpatient clinic for the study assessment:
Glasgow Outcome Scale- Extended
Rivermead Postconcussion Questionnaire
Quality of Life after Brain Injury (QOLIBRI)
Trail Making Test- TMT (Alter 20-85+)
Montreal Cognitive Assessment
Geriatrisches Screening nach Lachs
Geriatric Depression Scale
Barthel- Index
General situation of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2018/05/07
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

i. Closed skull-brain trauma
ii. Outpatient / inpatient treatment in our clinic since 01/01/2014
iii. Age> 60 years, no maximum age
iv. CCT imaging
v. Sufficient language skills
vi. consent form

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Exclusion Criteria

i. Open skull-brain trauma
ii. Polytrauma
iii. Age <60 years
iv. Missing CCT imaging
v. Missing consent
vi. Lack of language skills
vii. Neurological disease

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Addresses

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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie der LMU München
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie der LMU
    • Ms.  PD Dr.  Viktoria  Bogner-Flatz 
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie der LMU München
    • Ms.  Dr. med.  Mareen  Braunstein 
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie der LMU
    • Ms.  Pia  Coburger 
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie der LMU
    • Nussbaumstr. 20
    • 80336  München
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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