Managing recurrent blood clots in cancer patients on anticoagulants
Management of Recurrent Venous Thromboembolism During Anticoagulant Treatment in Cancer Patients - a Prospective Cohort Study
This study is testing how well adjusting blood thinner doses helps cancer patients who keep getting blood clots while on treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 9 sites (Chieti and 8 other locations) |
| Trial ID | NCT05229471 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical outcomes of cancer patients experiencing recurrent venous thromboembolism (VTE) while receiving anticoagulant treatment. It is an international, prospective, observational cohort study that will follow patients managed according to guideline-recommended dose escalation of low molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs). Eligible participants include adults with active cancer and confirmed recurrent VTE, while those with certain medical conditions or prior anticoagulant treatment will be excluded. The study will assess the effectiveness of these treatment strategies over a specified period.
Who should consider this trial
Good fit: Ideal candidates for this study are adult cancer patients who have experienced symptomatic or incidental recurrent VTE while on anticoagulant therapy.
Not a fit: Patients who have been on anticoagulant treatment for recurrent VTE for more than 72 hours or have severe hepatic dysfunction or active bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve management strategies for recurrent VTE in cancer patients, potentially leading to better clinical outcomes.
How similar studies have performed: While this approach is based on established guidelines, the specific management of recurrent VTE in cancer patients during anticoagulant treatment is an area that has not been extensively studied, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented active cancer (i.e. diagnosis of cancer within the past 6 months; recurrent, regionally advanced, or metastatic disease; currently receiving treatment or received treatment within the past 6 months) * Objectively confirmed symptomatic or incidental recurrent VTE while on anticoagulant therapy. The previous VTE and index recurrent VTE will include symptomatic or incidentally detected proximal deep vein thrombosis (DVT) of the lower extremities; symptomatic proximal upper extremity DVT (either related to a catheter or not); symptomatic distal DVT; symptomatic or incidentally detected multiple subsegmental, segmental or more proximal pulmonary embolism (PE). Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Use of thrombolysis * Anticoagulant treatment for the recurrent VTE for longer than 72 hours * Treatment with fondaparinux, unfractionated heparin, prophylactic doses of LMWH, or VKAs at time of recurrent VTE * Acute hepatitis, chronic active hepatitis, or severe hepatic dysfunction (Child Pugh C or \<MELD \> 10) * Active bleeding * Recent major surgery (\<2 weeks or longer, if still at high risk for bleeding) * Uncontrolled hypertension (systolic arterial pressure \>160 mmHg) * Known bleeding diathesis * Platelet count \<50.000 mm3 * Creatinine clearance \<30 mL/min (Cockcroft-Gault formula) * Life expectancy of less than 1 month * Dual antiplatelet therapy or aspirin at doses ≥165 mg daily * Current diagnosis or history of heparin-induced thrombocytopenia * Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study. * Suspected non-compliance at the time of recurrent VTE
Where this trial is running
Chieti and 8 other locations
- Gabriele D'Annunzio University — Chieti, Italy (Recruiting)
- Meander Medisch Centrum — Amersfoort, Netherlands (Recruiting)
- Amsterdam UMC, location AMC — Amsterdam, Netherlands (Recruiting)
- Leids Universitair Merisch Centrum — Leiden, Netherlands (Recruiting)
- Hospital Universitario Puerto Real — Cadiz, Spain (Recruiting)
- hospital general universitario de Elche — Elche, Spain (Recruiting)
- Clínica Universidad Navarra en Madrid — Madrid, Spain (Recruiting)
- Clinica Universidad de Navarra — Pamplona, Spain (Recruiting)
- Hospital Universitario Virgen del Rocío — Sevilla, Spain (Recruiting)
Study contacts
- Study coordinator: Floris Bosch, Drs.
- Email: f.t.bosch@amsterdamumc.nl
- Phone: 0031 20 5668791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.