Clinical trial · Interventional
Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
Multicentric, Randomized, Placebo Controlled and Double-blind Study to Evaluate the Efficacy and Safety of Antithrombotic Prophylaxis With Bemiparin (3,500 UI/Day) in Cancer Patients With a Central Venous Catheter (CVC)(BECAT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor stopped due to difficulties to recruit 402 patients required by protocol
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to prevent CVC-related deep venous thrombosis (CVC-DVT)
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 |
| Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bemiparin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bemiparin
- interventionNames
- Drug: Bemiparin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
- measure
- Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years old of either sex who have given their informed consent to participate in the study. * Patients with a neoplastic process, with a CVC for the administration of anti-tumoral treatment or any other treatment related to the neoplastic process. * Patients with a platelet count above 30,000/mm3. * Patients with no hemorrhagic symptomatology at the time of their inclusion Exclusion Criteria: * Patients with a history of clinically evident hemorrhagic episodes and/or with increased bleeding due to any other homeostatic alteration that contraindicates anticoagulant treatment and/or in the past two months have presented at least one of the following: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms). * Major surgery in the past two months. * Known hypersensitivity to LMWH, heparin or substances of porcine origin. * Patients with congenital or acquired bleeding diathesis. * Damage to or surgical interventions of the central nervous system, eyes and ears within the past 6 months. * Acute bacterial endocarditis or slow endocarditis. * Patients with a history of heparin-associated thrombocytopenia. * Patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic insufficiency (with values of AST and/or ALT \> 5 times the normal value established by the reference range of the local hospital laboratory). * Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg). * Patients with suspected inability/or inability to comply with treatment and/or complete the study. * Patients who are participating in another clinical trial or have done so in the past 30 days. * Patients with a life expectancy less than 3 months. * Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study. * Patients on treatment with anticoagulants or who have been on treatment during the week previous to insert the CVC (including prophylaxis with heparin for hepatic veno-occlusive disease). * Patients diagnosed with acute leukemia or awaiting a transplant from hematopoietic progenitors during the 90 days of the study.
References
Publications (0)
Data not yet available