Trial document





This trial has been registered retrospectively.
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  DRKS00017044

Trial Description

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Title

Thyroid diseases in patients with cerebral sinus venous thrombosis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Cerebral venous sinus thrombosis (CVST) is a rare disease with an estimated incidence of approximately 0.5/100.000/year (Stam 2005, Bousser 2007) to about 2/100.000/year (Mak2001, Janghorbani2007, Coutinho2012), and accounts for only a small proportion of about 1% of stroke in general. Possible underlying causes or risk factors span a broad spectrum of conditions. These range from focal - like infections of the central nervous system, traumas or arteriovenous malformations - to systemic disorders like cancer, hematological disorders or prothrombotic conditions (genetic and acquired).
Within this extensive list of comorbidities and potential causes, thyroid disorders have rarely been described as a potential underlying factor. An increasing number of case reports shows an association of CVST with hyperthyroidism in particular while a sufficient pathophysiological explanation is still lacking. Available data suggest a link between hyperthyroidism and moderate hypothyroidism with prothrombotic predilection or hypercoagulability.
Based on the aforementioned general association of thyroid diseases and thromboembolism or hypercoagulability and the increasing number of case reports on hyperthyroidism and CVST, we performed a retrospective analysis of all documented cases of CVST in our department and re-evaluated of risk factors and causes including thyroid diseases, with the aim to examine the relevance of thyroid diseases and hyperthyroidism in particular as a possible risk factor for CVST.

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Brief Summary in Scientific Language

Cerebral venous sinus thrombosis (CVST) is a rare disease with an estimated incidence of approximately 0.5/100.000/year (Stam 2005, Bousser 2007) to about 2/100.000/year (Mak2001, Janghorbani2007, Coutinho2012), and accounts for only a small proportion of about 1% of stroke in general. Possible underlying causes or risk factors span a broad spectrum of conditions. These range from focal - like infections of the central nervous system, traumas or arteriovenous malformations - to systemic disorders like cancer, hematological disorders or prothrombotic conditions (genetic and acquired).
Within this extensive list of comorbidities and potential causes, thyroid disorders have rarely been described as a potential underlying factor. An increasing number of case reports shows an association of CVST with hyperthyroidism in particular while a sufficient pathophysiological explanation is still lacking. Available data suggest a link between hyperthyroidism and moderate hypothyroidism with prothrombotic predilection or hypercoagulability.
Based on the aforementioned general association of thyroid diseases and thromboembolism or hypercoagulability and the increasing number of case reports on hyperthyroidism and CVST, we performed a retrospective analysis of all documented cases of CVST in our department and re-evaluated of risk factors and causes including thyroid diseases, with the aim to examine the relevance of thyroid diseases and hyperthyroidism in particular as a possible risk factor for CVST.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017044
  •   2019/08/06
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  •   yes
  •   Approved
  •   229/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I67.6 -  Nonpyogenic thrombosis of intracranial venous system
  •   E03 -  Other hypothyroidism
  •   E05 -  Thyrotoxicosis [hyperthyroidism]
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Interventions/Observational Groups

  •   Retrospective data evaluation (1996 - current), database search (KIS) for patients with sinus vein thrombosis and hyper- or hypothyroidism
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Characteristics

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

Secured diagnosis of cerebral sinus venous thrombosis and thyroid disorder, retrospective data analysis from KIS

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/06/19
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Secured diagnoses cerebral venous sinus thrombosis and thyroid disorder

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Neurozentrum
    • Mr.  Dr.  Johann  Lambeck 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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    • Neurozentrum
    • Mr.  Dr.  Johann  Lambeck 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  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.