Trial document




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  DRKS00008749

Trial Description

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Title

Long-term observational study for the assessment of the risk factors for clinical course and functional outcome of the individuals with cerebral aneurysms

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Trial Acronym

ARCTICA - Assessment of Risk Clusters for Treatment of Individuals with Cerebral Aneurysms

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URL of the Trial

http://www.jabbarli.com/arctica

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Brief Summary in Lay Language

The ARCTICA is a long-term study for the observation of the natural course of patients with cerebral aneurysms from the time of first diagnosis up to the eventual treatment and further (post-treatment) clinical course.
We aim at identifying the specific factors and associations which could have a meaningful impact on the clinical course and condition of diseased individuals.
The results of our study should bring essential data for further optimization of current treatment strategies and establishment of a risk management concept for avoidance of secondary complications. That all can improve the functional outcome of patients with cerebral aneurysms.

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Brief Summary in Scientific Language

The aim of the current study is the assessment of potential medical and aneurysm-specific risk factors that could have a significant impact on the severity of the clinical course and functional outcome of individuals with cerebral aneurysms.
Different demographic and clinical characteristics of patients, radiological features of identified cerebral aneurysms, previously applied treatment strategies, early and delayed complications, as well as short- and long-term functional outcome parameters are going to be collected within ARCTICA study for further statistical evaluation.
The functional outcome will be assessed with the use of modified Rankin scale, Glasgow outcome scale and specialized questionnaire for the evaluation of the life quality (SF-36).
The evaluation of presently reported risk scores, as well as the development of new risk scores upon the identified predictors of different complications and functional outcome of diseased patients is the goal of the ARCTICA-Study.
The implementation of the study results into the optimization of the current treatment strategies for aneurysm patients is also aimed by this study.

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Organizational Data

  •   DRKS00008749
  •   2015/06/09
  •   [---]*
  •   yes
  •   Approved
  •   15-6331-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I67.1 -  Cerebral aneurysm, nonruptured
  •   I60.9 -  Subarachnoid haemorrhage, unspecified
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Interventions/Observational Groups

  •   Observational arm with the evaluation of risk factors for the natural course, treatment complications, as well as late complications in case of the rupture of cerebral aneurysms with consecutive subarachnoid hemorrhage.
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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

Collection of demographic, clinical and radiographic parameters of patients with consecutive assessment of their value as risk factors for the natural course, treatment complications and late complications during subarachnoid hemorrhage; this data should be collected with the use of specialized check lists with predefined and optional parameters at the first contact with the patient and by clinical documentations during the hospital stay and in later regular ambulatory follow-ups; subsequently statistical analyses with univariate and multivariate assessments are going to be performed.

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Secondary Outcome

The validation and verification of applicability of previously reported risk scores as the basement for the development of risk management concepts and optimization of the current treatment strategies for the patients with cerebral aneurysms.
Development of new Risk Scores upon the study results.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/07/01
  •   3000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   100   Years
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Additional Inclusion Criteria

1. Presence of one or more cerebral aneurysm(s) on the digital subtraction angiography, computed tomography angiography and/or magnetic resonance angiography.
2. Hospital stay in the participating neurosurgical department

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Exclusion Criteria

1. The presence of an only flow-associated aneurysm (with any other intracranial vascular malformation);
2. Only extradural location of an aneurysm(s).

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Addresses

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    • Neurosurgeon
    • Mr.  Dr.  Ramazan  Jabbarli 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Neurosurgeon
    • Mr.  Dr.  Ramazan  Jabbarli 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Neurosurgeon
    • Mr.  Dr.  Ramazan  Jabbarli 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für NeurochirurgieUniklinik Essen
    • Mr.  Dr. med.  Ramazan  Jabbarli 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.