Trial document





This trial has been registered retrospectively.
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  DRKS00016532

Trial Description

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Title

Prospective registry for cerebral aneurysms and vascular malformations

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Trial Acronym

PRISMA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Intracerebral hemorrhage due to rupture of cerebral aneurysms and vascular malformations is associated with high morbidity and mortality. Mobidity and mortality is due to both modifiable and non-modifiable causes. A structured documentation of these causes and their treatments enables a better understanding of the underlying disease. Treatment of modifiable causes of morbidity and mortality may improve outcome. The risk for the rupture of a cerebral aneurysm or vascular malformation may be improved by a precise documentation of its natural course. Patient counselling and treatment may be improved by enhancing our knowledge about cerebral aneurysms and vascular malformations.

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Brief Summary in Scientific Language

Cerebral aneurysms and vascular malformations of the brain are rare disorders. They represent a substantial health risk in affected patients due to their inherent risk for rupture. Their pathogenesis remains unknown. Optimal methods of diagnosis, surveillance, therapy and follow-up are the subject of current research. The goal of the PRISMA registry is to enhance our knowledge about the causes, natural course, diagnostic and therapeutic concepts and long-term outcome of cerebral aneurysms and vascular malformations. Therefore, all patients admitted to the Neurocenter of the Medical Center - University of Freiburg who are willing to participate will be prospectively enroled in the PRISMA registry. Relevant health care data are recorded and a structured and objective follow-up is performed. The PRISMA registry is the foundation for research aiming at the improvement of patient counselling, diagnosis and therapy.

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Organizational Data

  •   DRKS00016532
  •   2019/05/15
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  •   yes
  •   Approved
  •   184/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   cerebral Aneurysms and vascular malformations
  •   Q28.0 -  Arteriovenous malformation of precerebral vessels
  •   I67.11 -  [generalization I67.1: Cerebral aneurysm, nonruptured]
  •   D18 -  Haemangioma and lymphangioma, any site
  •   I60 -  Subarachnoid haemorrhage
  •   I67 -  Other cerebrovascular diseases
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Interventions/Observational Groups

  •   Prospectiv observation of patients with cerebral aneurysms and vascular malformations
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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)
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  •   N/A
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Primary Outcome

Outcome after 6 and 12 month

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Secondary Outcome

Delayed cerebral infarction,
Shunt dependent hydrocephalus,
Quality of Life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/01/04
  •   320
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with ruptured and unruptured cerebral aneurysms and vascular malformations

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinik Freiburg, Klinik für Neurochirurgie
    • Mr.  Dr.  Roland  Rölz 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Klinik für Neurochirurgie
    • Mr.  Dr.  Roland  Rölz 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Klinik für Neurochirurgie
    • Mr.  Dr.  Roland  Rölz 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Freiburg, Klinik für Neurochirurgie
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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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.