Predicting venous thromboembolism with the FGT test in patients with pancreatic cancer

Recruiting

Conditions: Venous thromboembolism, arterial thromboembolism

Registration Number: NL-OMON19867

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 112

Inclusion Criteria

•Adenocarcinoma of the pancreas confirmed by histology or radiologic imaging.
•Planned for a new course 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 within the last month
•Start of chemotherapy before enrolment
•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.
•Chemotherapy in the last month

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>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. <br>

Secondary Outcome Measures

Name	Time	Method
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.