Cerebral Venous Thrombosis Clinical Trial
Official title:
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.
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