Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Harry R. Buller
- Enrollment
- 900
- Locations
- 7
- Primary Endpoint
- venous thromboembolism
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism, collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer patients have been previously developed by the groups of Khorana and Vienna CATS. However, routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently not recommended. In the investigators prospective, observational cohort study, the investigators aim to identify cancer patients at high risk for VTE based on clinical characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing microparticles.
Investigators
Harry R. Buller
Harry R Büller, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
Inclusion Criteria
- •Stage III or IV esophageal carcinoma, gastric carcinoma, intestinal carcinoma, pancreatic carcinoma, ovarian cancer, breast carcinoma, prostate cancer, urothelial cell carcinoma or lung carcinoma (small cell or non-small cell) who have started chemotherapy no more than 3 months ago
- •Chemotherapy started no more than 3 months ago or within 7 days after enrollment
- •Aged 18 years or older
- •Written informed consent
Exclusion Criteria
- •Use of anticoagulants (heparin, vitamin K antagonists or direct oral anticoagulants)
- •Adjuvant chemotherapy (i.e. after surgery with curative intent)
Outcomes
Primary Outcomes
venous thromboembolism
Time Frame: 6 months after enrollment
Objectively confirmed asymptomatic or symptomatic deep venous thrombosis or pulmonary embolism
Secondary Outcomes
- all-cause mortality(6 months after enrollment)