D-dimer and Factor XIII activation peptide in cerebral venous thrombosis (CVT)

Cerebral venous and sinus thrombosis (CVT) is a relatively uncommon form of
stroke. The clinical spectrum of CVT can be extremely diverse which makes
diagnosis of CVT a challenging job for physicians. CT-venography or
MR-venography are costly, not always available on a emergency basis,
time-consuming and, in the case of CT-V, submit the patient to a significant
level of radiation. A simpler test to exclude CVT like D-dimer concentration
and/or the newly investigated FXIII activation peptide (AP-FXIII) concentration
would be welcome. However, the diagnostic value of these tests are still under
debate and further research is required.

To assess the sensitivity and negative predictive values of D-dimer- and FXIII
activation peptide (AP-FXIII) values in order to exclude to exclude CVT in
patients with clinical suspicion of CVT.

Observational prospective multi-centre cohort study. Consecutive patients with
clinical suspicion of CVT 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. Participation
in the study has no influence on treatment decision. On admission patients will
undergo a standard diagnostic work-up, including a clinical neurological
examination, routine laboratory examination and brain CT-venography or MRI/MRV.
For the study D-dimer values and plasma AP- FXIII will be analyzed at the
Hemostasis Research Laboratory, Department of Hematology, AMC according to a
newly developed highly sensitive and specific ELISA method. The laboratory
technician 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.

There are no personal benefits for participating subjects. Their participation
may help patients in the future suspected of CVT. Aside from the inconvenience
of undergoing a venapunction, there are no risks associated with participation
in this study.