Predicting venous thromboembolism in patients with pancreatic cancer.

Recruiting

Conditions: blood clot
venous thromboembolism
10014523

Registration Number: NL-OMON52393

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

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

* Adjuvant chemotherapy.
* Current prophylactic or therapeutic anticoagulant therapy (unfractionated
heparin, low molecular weight heparin, vitamin K antagonists, or direct oral
anticoagulants).
* Venous thromboembolism < 3 months prior to chemotherapy.
* Surgery or chemotherapy within the last month
* The presence of an inferior vena cava filter
* Currently pregnant
* Life expectancy of <3 months
* Bacterial or viral infection in the previous 2 weeks, defined by fever and
clinical symptoms.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The purpose of current study is to evaluate the predictive performance of the<br /><br>improved FGT for the development of VTE in pancreatic cancer patients. The<br /><br>primary outcome is<br /><br>VTE occurring within 6 months from enrolment, including any symptomatic<br /><br>proximal and distal DVT of the upper or lower limbs, any non-fatal symptomatic<br /><br>or incidental segmental of more proximal PE, VTE-related deaths (fatal PE or<br /><br>unexplained death), as well as all other sites of VTE (distal upper & lower<br /><br>DVT, cerebral vein, splenic vein, renal vein, gonadal vein). Catheter related<br /><br>venous thromboembolism will not be considered as the primary outcome. The<br /><br>diagnosis needs to be confirmed by an independent radiologist by means of<br /><br>ultrasonography or computed tomography. No routine radiologic imaging will be<br /><br>performed for this study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study outcome is the occurrence of arterial thrombotic events<br /><br>(ATE). Acute myocardial infarction and ischemic stroke will be considered as<br /><br>ATE. Other secondary outcomes are portal, mesenteric, and hepatic vein<br /><br>thrombosis.<br /><br><br /><br>Other study parameters are several other (bio)markers or patient<br /><br>characteristics which are known to be predictive of VTE. These are the<br /><br>TF-dependent factor Xa generation test, microvesicle tissue factor activity<br /><br>assay, factor XIa-C1 esterase inhibitor complexes, tPA-mediated clot lysis<br /><br>time, active PAI-1, Nucleosomes and cell free DNA, citrullinated histone H3<br /><br>(H3Cit), D-dimer, prothrombin fragment 1+2, clotting factor VIII, X, XI and XII<br /><br>activity, von Willebrand factor antigen, platelet factor 4, soluble P-selectin,<br /><br>tissue factor pathway inhibitor (TFPI), and 12 genetic variants from the TiC<br /><br>score.</p><br>