blood cloth cancer
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with active cancer and acute venous thromboembolism (VTE) in whom anticoagulant therapy is anticipated 2. Patients with active cancer and no suspicion or history of VTE 3. Patients with acute venous thromboembolism in whom anticoagulant therapy is anticipated, with no history of cancer or cancer treatment in the past 5 years and no suspicion of cancer at study entry. 4. Healthy volunteers • No history of cancer or cancer-related therapy in the past 5 years. • No history of VTE • No suspicion of cancer or VTE at study entry • No hospital admission in the past 6 months
Exclusion criteria
Exclusion criteria: • Arterial thrombosis (ischemic stroke, myocardial infarction, peripheral arterial thrombosis) in the past six months • Ongoing anticoagulant or antiplatelet therapy • Mechanical heart valves • Central venous catheters within 4 weeks prior to inclusion, or anticipated placement. • One or more of the following risk factors for VTE: - Known hereditary or acquired thrombophilia - Viral or bacterial infection at time of inclusion - Surgery, trauma or fracture of the leg within the previous 4 weeks - Current known pregnancy - Current estrogen therapy • Inability for blood withdrawal at baseline • Inability or refusal to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the level of factor IXa-antithrombin (FIXa:AT). The FIXa:AT complex reflects an early part of the coagulation cascade, and relatively late part of the intrinsic coagulation pathway, immediately prior to factor X and prothrombin conversion. FIXa:AT thereby provides the most accurate estimation of intrinsic pathway activation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study outcomes are: 1. Factor XIIa-, factor XIa-, and kallikrein (PKa)-inhibitor complexes: FXIIa-C1inh, FXIIa:AT, FXIa-C1inh, FXIa-AT, FXIa:a1AT, and PKa:C1inh complexes 2. FXIa-dependent thrombin generation test 3. Cancer-related activators of the intrinsic pathway: NET-formation markers (myeloperoxidase, nucleosomes, and citrullinated histone H3), cell-free DNA and polyphosphate extracellular vesicles 4. Extrinsic pathway activation and cancer-related activators: FVIIa-AT complexes and TF extracellular vesicles. See protocol section 5.1.2 for details. | — |
Countries
Netherlands
Outcome results
None listed