Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
- Registration Number
- NCT00311896
- Lead Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Brief Summary
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)
- Detailed Description
Venous thromboembolism (VTE) is a common complication in patients with cancer principally in association with central vein catheters (CVC). The clinical benefit of antithrombotic prophylaxis for CVC-related VTE in cancer patients remains unclear.The aim of this study is to evaluate the efficacy and safety of the administration of Bemiparin in cancer patients with a central venous catheter (CVC). This study is designed as a multicenter, randomized, double-blind, placebo-controlled study. On the day of CVC insertion, eligible patients are randomly assigned to receive subcutaneously either bemiparin (3,500 UI/day) or placebo by using preloaded syringes for 45 days.
The primary efficacy endpoint will be the combined incidence during the double blind treatment period of Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography)and subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 402
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Bemiparin Bemiparin -
- Primary Outcome Measures
Name Time Method Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography). Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
District Emergency Clinical Hospital
🇷🇴Targu-Mures, Romania
Hospital ClÃnico San Carlos-Madrid.
🇪🇸Madrid, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
ClÃnica Universitaria de Navarra
🇪🇸Pamplona, Spain
Cenral Emergency Clinical Military H.
🇷🇴Bucharest, Romania
University "CF" Clinical Hospital
🇷🇴Cluj-Napoca, Romania
Filantropia District Hospital
🇷🇴Craiova, Romania
Oncology Institute Cuj-Napoca
🇷🇴Cluj-Napoca, Romania
Oncology Medical Center, Iasi
🇷🇴Iasi, Romania
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Complejo Hospitalario de Donostia
🇪🇸San Sebastian, Spain
Instituto Valenciano de OncologÃa
🇪🇸Valencia, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Arad County Hospital
🇷🇴Arad, Romania
Sf Maria Clinical Hospital
🇷🇴Bucharest, Romania