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

This study is currently recruiting participants.
Verified September 2017 by University Hospital Inselspital, Berne
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924859
First Posted: June 19, 2009
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Schweizerische Herzstiftung
Information provided by:
University Hospital Inselspital, Berne
June 15, 2009
June 19, 2009
September 28, 2017
September 2009
December 31, 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00924859 on ClinicalTrials.gov Archive Site
  • The overall frequency of CVT in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ]
  • The overall frequency of other diseases in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ]
  • The site of involved veins and sinus in patients with CVT [ Time Frame: at hospital entry ]
Same as current
Not Provided
Not Provided
 
The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)
The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis
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.

Background

Because of the broad clinical spectrum it is often difficult to establish the diagnosis of cerebral venous thrombosis (CVT). Combined MRI/MRV and contrast-enhanced CT are the most accurate methods for diagnosis of CVT. However these methods are often not available on an emergency basis. This stresses the need for additional widely available tests such as coagulation markers to exclude CVT. The diagnostic value of D-dimer levels for the exclusion of CVT is still under debate. Other potential coagulation markers have not been systematically investigated. 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. Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital Bern will be included in this study over a two year period. All included patients will receive standard care applied by the treating physician who will follow international recommendations. Patient involvement in the study shall not influence any treatment decision. On admission patients will undergo a complete diagnostic work-up, including a clinical neurological examination, standard laboratory examination including D-dimer values, and brain contrast CT and/or MRI/MRV. In addition, plasma FXIII-AP will be analyzed. FXIII-AP will be analyzed at the Hemostasis Research Laboratory, Department of Hematology, University of Bern, based on a newly developed highly sensitive and specific ELISA method. The investigators will be blinded for the clinical symptoms and diagnosis of the patient. The study will be conducted according to the guidelines of the STARD (Standards for Reporting Diagnostic Accuracy) initiative.

The following primary evaluation criteria will be analysed:1) The overall diagnostic accuracy of FXIII-AP to exclude CVT in patients with clinical suspicion of CVT; 2) The overall diagnostic accuracy of D-dimer to exclude CVT in patients with clinical suspicion of CVT; 3) Roc curves will be calculated.

Prespecified subgroup analyses will be performed according to the clinical presentation: 1) isolated headache; 2) isolated intracranial hypertension (headache and papilledema); 3) Focal neurological deficits and/or seizures and/or disturbances of consciousness. Furthermore, prespecified subgroup analyses will be performed according to modes of onset: 1) acute (symptoms < 48 hours duration); 2) subacute (symptoms > 48 hours and < 7 days duration); 3) chronic (symptoms > 7 days duration).

The following secondary evaluation criteria will be assessed: 1) The overall frequency of CVT in patients with clinical suspicion of CVT; 2) The overall frequency of other diseases in patients with clinical suspicion of CVT; 3) The site of involved veins and sinus in patients with CVT.

Objective

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.

Methods

Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital Bern will be included in this study over a two year period. All included patients will receive standard care applied by the treating physician who will follow international recommendations. D-dimer measurement at entry will be performed using a rapid sensitive assay. FXIII-AP will be analyzed at the Hemostasis Research Laboratory, Department of Hematology, University of Bern based on a highly sensitive and specific ELISA method.The investigators will be blinded for the clinical symptoms and diagnosis of the patient.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital (tertiary care clinic)
Cerebral Venous Thrombosis
Other: ELISA Test
assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test
1
Patients with clinical suspicion of CVT
Intervention: Other: ELISA Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 31, 2017
December 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact: Marcel Arnold, MD Prof. +41316323332 Marcel.Arnold@insel.ch
Netherlands,   Switzerland
 
 
NCT00924859
112/09
No
Not Provided
Not Provided
Departement of Neurology, Inselspital Bern, Universitiy Hospital
University Hospital Inselspital, Berne
Schweizerische Herzstiftung
Principal Investigator: Marcel Arnold, MD Prof. Dep. of Neurology, Bern University Hospital
University Hospital Inselspital, Berne
September 2017