Trial document





This trial has been registered retrospectively.
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  DRKS00010525

Trial Description

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Title

A prospective study on epidemiology and outcome of patients with traumatic brain injury (TBI) in BG-hospitals

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Trial Acronym

ProSHT

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is the documentation of treatment and outcome of patients after traumatic brain injury (TBI) who are treated in one of the participating hospitals. Especially factors which have an negative impact on clinical outcome should be identified. In a subproject, the frequency and temporal dynamics of neuropsychological deficits will be assessed in a subgroup of patients with mild TBI (concussion). Patients are examined within the first 4 weeks after trauma, and 3 and 12 months later. Besides, the possible value of new MRI-techniques as a prognostic parameter in mild TBI wil be determined.

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Brief Summary in Scientific Language

The study consists of two different parts, an epidemiological main project (“TBI registry”), and an additional subproject (“mild TBI”). In the TBI registry, all patients with different degrees of TBI who are newly diagnosed and treated between 01.10.2014 and 30.09.2015 in the participating hospitals will be prospectively documented, and a 1-year follow up will be performed. The aim is to document the current state of diagnosis and treatment of patients with TBI in the participating hospitals. Besides, another aim is to document the outcome of patients who have suffered from TBI, and to identify risk factors determining a negative course of the disease. In the subproject, the frequency and temporal dynamics of neuropsychological deficits will be assessed in a subgroup of patients with mild TBI. Besides, the possible value of new MRI-techniques (especially DTI) as a prognostic parameter in mild TBI wil be determined.

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Organizational Data

  •   DRKS00010525
  •   2016/05/17
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  •   yes
  •   Approved
  •   4466-12, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   S06 -  Intracranial injury
  •   S09 -  Other and unspecified injuries of head
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Interventions/Observational Groups

  •   Treatment of patients with traumatic brain injury (TBI) will be documented (documentation forms: initial, acute, rehabilitation), and telefone interviews will be performed after 3 and 12 months. In a subgroup of patients with mild TBI, MRI will be performed within the first 4 weeks after trauma, as well as 3 and 12 months later, and neuropsychological assessment will take place 3 and 12 months after trauma.
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Characteristics

  •   Non-interventional
  •   Epidemiological 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

The aim of this study is to generate epidemiological data on medical care and outcome of patients with traumatic brain injury who are treated in BG hospitals in Germany. The current state of medical care in these hospitals is described by 3 standardized assessment forms. Besides, outcome of these patients is assessed by 2 standardized telephone interviews, which take place 3 and 12 months after trauma. Riisk factors for negative outcome after TBI shall be idenbtified.

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Secondary Outcome

Abnormalities in neuropsychological examination 12 months after mild traumatic brain injury. Neuropsychological examination consists of cognitive tests (attention, verbal and nonverbal memory, cognitive speed, working memory, verbal fluency and validation of complaints) and self-reporting questionnaires on depression, anxiety and attention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   3000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Epidemiological main project:
Patient with acute head injury, at least 18 years old, presentation at one of the participating hospitals within 24 hours afgter trauma and
1.At least one of the following symptoms:
-nausea/vomitting
-headache
-anterograde/retrograde amnesia
-impaired consciousness
-fracture of skull or face
-focal neurological sign

and/or

2. One of the following diagnosis:
- S02 Fracture of skull and facial bones
- S04 Injury of cranial nerves
- S06 Intracranial injury
- S07 Crushing injury of head
- S09 Other and unspecifed injuries of head

Subproject "mild TBI":
Patient with mild TBI, defined by head injury and at least one of the following conditions:
-transient loss of consciousness <30min
-amnesia <24h
-transient qualitative or quantitative impairment of consciousness
-GCS 30 min after trauma between 13 and 15

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Exclusion Criteria

main project:
age <18y

subproject:
-focal neurological sign
-intracranial bleeding or skull fracture as revealed by CCT
-relevant accompanying disorders
-history of neurological or psychiatric disorder
-contraindication for MRI
-insufficient knowledge of German language

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Addresses

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    • BG Universitätsklinikum Bergmannsheil
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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    • Neurologische Klinik, BG-Universitätsklinikum Bergmannsheil
    • Mr.  Prof. Dr.  Peter  Schwenkreis 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochumj
    • Germany
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    • Neurologische Klinik, BG-Universitätsklinikum Bergmannsheil
    • Mr.  Prof. Dr.  Peter  Schwenkreis 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • DGUV-Forschungsförderung
    • Alte Heerstr. 111
    • 53757  St. Augustin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.