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The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)

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ClinicalTrials.gov Identifier: NCT00924859
Recruitment Status : Recruiting
First Posted : June 19, 2009
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Schweizerische Herzstiftung
Information provided by:
University Hospital Inselspital, Berne

Study Description
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Brief Summary:
The investigators aim to assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test, to exclude CVT in patients with clinical suspicion of CVT.

Condition or disease Intervention/treatment
Cerebral Venous Thrombosis Other: ELISA Test

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Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis
Actual Study Start Date : September 2009
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Patients with clinical suspicion of CVT
 Other: ELISA Test
assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test


Outcome Measures
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Primary Outcome Measures :
  1. The overall diagnostic accuracy of FXIII-AP an D-dimer to exclude CVT in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ]

Secondary Outcome Measures :
  1. The overall frequency of CVT in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ]
  2. The overall frequency of other diseases in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ]
  3. The site of involved veins and sinus in patients with CVT [ Time Frame: at hospital entry ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital (tertiary care clinic)
Criteria

Inclusion Criteria:

  • Adults with clinical suspicion of CVT
  • Isolated unexplained headache of less than 30 days duration
  • Headache associated with focal central neurological deficits of less than 30 days duration
  • Headache associated with disturbed consciousness of less than 30 days duration
  • Headache associated with epileptic seizures of less than 30 days duration
  • Unexplained papilledema of less than 30 days duration

Exclusion Criteria

  • Deep venous thrombosis within 3 months prior to admission
  • Pulmonary embolism within 3 months prior to admission
  • Ischemic stroke within 3 months prior to admission
  • Myocardial infarction within 3 months prior to admission
  • Other vascular disease within 3 months prior to admission
  • Headache due to trauma
  • Malignant neoplasia
  • Treatment with anticoagulants prior to admission
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924859


Contacts
Contact: Marcel Arnold, MD Prof. +41316323332 Marcel.Arnold@insel.ch

Locations
Netherlands
Department of Neurology, Academic Medical Centre, University of Amsterdam Recruiting
Amsterdam, Netherlands, 1100
Contact: J. Coutinho, Dr.    +31 20 5664591    j..coutinho@amc.uva.nl   
Principal Investigator: J. Stam, Prof.         
Principal Investigator: J. Coutinho, Dr.         
Switzerland
Dep. of Neurology, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Principal Investigator: Marcel Arnold, MD Prof.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Schweizerische Herzstiftung
Investigators
Principal Investigator: Marcel Arnold, MD Prof. Dep. of Neurology, Bern University Hospital
More Information
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Responsible Party: Departement of Neurology, Inselspital Bern, Universitiy Hospital
ClinicalTrials.gov Identifier: NCT00924859     History of Changes
Other Study ID Numbers: 112/09
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by University Hospital Inselspital, Berne:
cerebral venous thrombosis
stroke
coagulation

Additional relevant MeSH terms:
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants