Clinical trial · Interventional
Residual Vein Thrombosis and the Optimal Duration of Low Molecular Weight Heparin in Cancer Patients With Deep Vein Thrombosis
Residual Vein Thrombosis Establishes the Optimal Duration of Low Molecular Weight Heparins in Cancer Patients With Deep Vein Thrombosis of the Lower Limbs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The duration of anticoagulant treatment in cancer patients with Deep Vein Thrombosis (DVT) of the lower limbs is still uncertain. The present study addresses the possible role of the Residual Vein Thrombosis (RVT) for establishing the optimal duration of Low Molecular Weight Heparin (LMWH). Patients with a first episode of symptomatic unprovoked or provoked proximal DVT will received LMWHs for 6 months; RVT, ultrasonographically-detected, will be then assessed. Patients without RVT stop LMWH, whereas those with RVT will be randomized to either stop or continue OAT for additional 6 months. Patients were followed-up at least 1 year after anticoagulant discontinuation focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Deep Vein Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low molecular weight heparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Recurrent Deep Vein Thrombosis and/or Pulmonary Embolism
- timeFrame
- 30 days
Secondary outcomes (2)
- measure
- Minor bleeding
- timeFrame
- 30 days
- measure
- Death due to cancer
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cancer patients with a first episode of symptomatic proximal DVT of the lower limbs * No signs of unstable pulmonary embolism Exclusion Criteria: * Indication to antithrombotic therapy/OAT for \> 6 months (i.e. valvular prothesis, atrial fibrillation etc.) * Previous DVT/PE * Hypersensitivity to contrast media * Pregnancy * Life expectancy \< 1 year * Patients who are unable to fulfill study requirements as for repeated clinical controls
References
Publications (1)
- DERIVEDNapolitano M, Saccullo G, Malato A, Sprini D, Ageno W, Imberti D, Mascheroni D, Bucherini E, Gallucci P, D'Alessio A, Prantera T, Spadaro P, Rotondo S, Di Micco P, Oriana V, Urbano O, Recchia F, Ghirarduzzi A, Lo Coco L, Mancuso S, Casuccio A, Rini GB, Siragusa S. Optimal duration of low molecular weight heparin for the treatment of cancer-related deep vein thrombosis: the Cancer-DACUS Study. J Clin Oncol. 2014 Nov 10;32(32):3607-12. doi: 10.1200/JCO.2013.51.7433. Epub 2014 Sep 29. PMID 25267738