blood clot venous thromboembolism
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Pancreatic cancer confirmed by histology or radiologic imaging. * Planned for a new line of chemotherapy * 18 years of age or older * Fully capable of making health related decisions and written informed consent.
Exclusion criteria
Exclusion criteria: * Adjuvant chemotherapy. * Current prophylactic or therapeutic anticoagulant therapy (unfractionated heparin, low molecular weight heparin, vitamin K antagonists, or direct oral anticoagulants). * Venous thromboembolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The purpose of current study is to evaluate the predictive performance of the improved FGT for the development of VTE in pancreatic cancer patients. The primary outcome is VTE occurring within 6 months from enrolment, including any symptomatic proximal and distal DVT of the upper or lower limbs, any non-fatal symptomatic or incidental segmental of more proximal PE, VTE-related deaths (fatal PE or unexplained death), as well as all other sites of VTE (distal upper & lower DVT, cerebral vein, splenic vein, renal vein, gonadal vein). Catheter related venous thromboembolism will not be considered as the primary outcome. The diagnosis needs to be confirmed by an independent radiologist by means of ultrasonography or computed tomography. No routine radiologic imaging will be performed for this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study outcome is the occurrence of arterial thrombotic events (ATE). Acute myocardial infarction and ischemic stroke will be considered as ATE. Other secondary outcomes are portal, mesenteric, and hepatic vein thrombosis. Other study parameters are several other (bio)markers or patient characteristics which are known to be predictive of VTE. These are the TF-dependent factor Xa generation test, microvesicle tissue factor activity assay, factor XIa-C1 esterase inhibitor complexes, tPA-mediated clot lysis time, active PAI-1, Nucleosomes and cell free DNA, citrullinated histone H3 (H3Cit), D-dimer, prothrombin fragment 1+2, clotting factor VIII, X, XI and XII activity, von Willebrand factor antigen, platelet factor 4, soluble P-selectin, tissue factor pathway inhibitor (TFPI), and 12 genetic variants from the TiC score. | — |
Countries
Netherlands
Outcome results
None listed