Trial document





This trial has been registered retrospectively.
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  DRKS00009609

Trial Description

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Title

Coma Outcome in Early Neurological Rehabilitation: A Prospective Registry of Long-Term Outcome in Patients with Severe Disorders of Consciousness After Acute Brain Injury

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Trial Acronym

KOPF-R

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URL of the Trial

http://www.klinikum.uni-muenchen.de/Klinik-und-Poliklinik-fuer-Neurologie/de/Forschung/Klinische_Studien/KOPFregister/index.html

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Brief Summary in Lay Language

KOPF-R is a clinical database used to examine characteristics, management, as well as functional and quality of life outcomes of patients with severe disorders of consciousness . It was set up in 5 facilities across the German state of Bavaria with special expertise in rehabilitation after acquired brain injury. Measures include sociodemographic and clinical characteristics, course of acute therapy, electrophysiological measures (evoked potentials, electroencephalogram), neuron-specific enolase, current medication, functioning, cognition, quality of life, quantity and characteristics of rehabilitation therapy, caregiver burden, and attitudes toward end-of-life decisions. Results are likely to have an impact on treatment decisions in the acute situation and in rehabilitation facilities, on treatment guidelines, and on the definition of clinical pathways.

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Brief Summary in Scientific Language

KOPF-R is a clinical database used to examine characteristics, management, as well as functional and quality of life outcomes of patients with severe disorders of consciousness . It was set up in 5 facilities across the German state of Bavaria with special expertise in rehabilitation after acquired brain injury. Measures include sociodemographic and clinical characteristics, course of acute therapy, electrophysiological measures (evoked potentials, electroencephalogram), neuron-specific enolase, current medication, functioning, cognition, quality of life, quantity and characteristics of rehabilitation therapy, caregiver burden, and attitudes toward end-of-life decisions. Results are likely to have an impact on treatment decisions in the acute situation and in rehabilitation facilities, on treatment guidelines, and on the definition of clinical pathways. Patients enrolled in KOPF-R presented at the time of admission to a participating rehabilitation center and immediately after intensive care treatment disorders of consciousness resulting from acute brain injury such as coma, vegetative state, or minimally conscious state. Entry into the registry does not depend on specific diagnoses, but on the level of consciousness as defined by the revised version of the Coma Recovery Scale. KOPF-R also includes the cases of patients considered for discontinuation of specific medical care or life-supportive care at the intensive care unit. Patients are admitted for rehabilitation irrespective of the results of initial prognostic markers, wherever possible and appropriate. The main exclusion criterion is application of continuous intravenous sedative drugs (eg, benzodiazepines, propofol) for artificial therapeutic coma. Intermittent administration of lorazepam (maximum dose, 3mg/d) is not part of the exclusion criteria. Prehospital findings and findings from the acute hospital ICU are retrieved from patient files. On admission to rehabilitation, data are collected prospectively from patients, patient files, and family members. Data collection was carried out by health professionals trained in data collection and data entry in this setting. Data was entered using a web-based electronic data system specifically designed for this purpose. Follow-up was carried out at 6 and 12 months and yearly thereafter for 5 years.

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Organizational Data

  •   DRKS00009609
  •   2015/12/02
  •   [---]*
  •   yes
  •   Approved
  •   414-09, 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

  •   R40.2 -  Coma, unspecified
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Interventions/Observational Groups

  •   In order to determine longterm outcome factors, we examine caregivers and patients with severe disorders of consciousness after acute brain injury within the framework of a multicenter prospective longitudinal observational study.
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Characteristics

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

Long-term outcome (after 6, 12, 24, 36 months) of initially comatose patients with a severe brain injury that considers functional status, quality of life and life participation, after they had used consistently neurorehabilitative options available to them.

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Secondary Outcome

The prognostic value of neurorehabilitation factors in the prediction of a long-term outcome and the psychosocial situation of caregivers.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2010/09/13
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   82   Years
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Additional Inclusion Criteria

Acute brain injury as for the referral to a rehabilitation facility.
A disorder of consciousness at admission, defined as coma, vegetative state or MCS (based on the Coma Recovery Scale - Revised scores).
Written informed consent from caregivers or legal guardian.
Patient/Caregiver/Legal Guardian have a sufficient command of the German language and place of residence in Germany.

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Exclusion Criteria

Application of continuous intravenous sedative drugs (e.g., benzodiazepines, propofol) for artificial coma

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Addresses

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Sources of Monetary or Material Support

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    • ZNS Hannelore Kohl Stiftung
    • Rochusstr. 24
    • 53123  Bonn
    • Germany
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    • Deutsche Stiftung Neurologie
    • Leopoldstr. 153
    • 80804  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/29
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* This entry means the parameter is not applicable or has not been set.