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)
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
Eduardo Rocha, MD
Clinica Universitaria de Navarra
Spain: Spanish Agency of Medicines