Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · Apr 5, 2006
Trial Information
Current as of August 31, 2025
Terminated
Keywords
ClinConnect Summary
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 bem...
Gender
ALL
Eligibility criteria
- 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.
About Clinica Universidad De Navarra, Universidad De Navarra
Clinica Universidad de Navarra, affiliated with Universidad de Navarra, is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and patient care. With a commitment to excellence, it integrates cutting-edge medical research with comprehensive clinical services, fostering an environment that promotes the development of new therapies and treatment protocols. The institution is recognized for its robust clinical trial programs, which aim to enhance patient outcomes and contribute to the global medical community's knowledge. Through collaboration with various research entities and a focus on ethical standards, Clinica Universidad de Navarra plays a pivotal role in translating scientific discoveries into practical applications in medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Zaragoza, , Spain
Barcelona, , Spain
Valencia, , Spain
Alicante, , Spain
Pamplona, Navarra, Spain
Arad, , Romania
Bucharest, , Romania
Bucharest, , Romania
Cluj Napoca, , Romania
Cluj Napoca, , Romania
Craiova, , Romania
Iasi, , Romania
Targu Mures, , Romania
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Murcia, , Spain
Pamplona, , Spain
San Sebastian, , Spain
Valencia, , Spain
Patients applied
Trial Officials
Eduardo Rocha, MD
Study Chair
Clinica Universitaria de Navarra
Ramon Lecumberri, MD
Principal Investigator
Clinica Universitaria de Navarra
Vicente Vicente, MD
Principal Investigator
Hospital Morales Meseguer
Pascual Marco, MD
Principal Investigator
Hospital General Universitario de Alicante
José Mateo, MD
Principal Investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Albert Font, MD
Principal Investigator
Germans Trias i Pujol Hospital
Carmen Arratibel, MD
Principal Investigator
Complejo Hospitalario de Donostia
Francisco J. Capote, MD
Principal Investigator
Hospital Universitario Puerta del Mar
Miguel Angel De gregorio Ariza, MD
Principal Investigator
Hospital Clinico Universitario Lozano Blesa-Zaragoza
Isabel Picón Roig, MD
Principal Investigator
Instituto Valenciano de Oncología
Ricardo González Del Val Subirats, MD
Principal Investigator
Hospital General Universitario Gregorio Marañón
Carlos Bosh Roig, MD
Principal Investigator
Hospital Universitario Doctor Peset
Pedro Pérez-Segura, MD
Principal Investigator
Hospital Clínico San Carlos-Madrid.
Vicente Alberola, MD
Principal Investigator
Hospital Arnau de Vilanova de Valencia
César Rodríguez Sánchez, MD
Principal Investigator
Hospital Clínico de Salamanca
Ignacio Alberca Silva, MD
Principal Investigator
Hospital Clínico de Salamanca
Javier García Frade, MD
Principal Investigator
Hospital del Rio Hortega
Carmen Sedano, MD
Principal Investigator
Hospital Marqués de Valdecilla
Natividad Gómez, MD
Principal Investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Amalia Velasco, MD
Principal Investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Carmen Rodríguez Pinto, MD
Principal Investigator
Hospital Universitario Central de Asturias
Mihai Ciochinaru, MD
Principal Investigator
Cenral Emergency Clinical Military H.
Cornelia Toganel, MD
Principal Investigator
District Emergency Clinical Hospital
Csaba Bela Szekely, MD
Principal Investigator
Arad District Hospital
Mihaela Danciulescu, MD
Principal Investigator
Filantropia District Hospital
Constantin Volovat, MD
Principal Investigator
Oncology Medical Center Iasi
Mircea Cazacu, Prof.
Principal Investigator
University "CF" Clinical Hospital
Eliade Ciuleanu, MD
Principal Investigator
Oncology Institute Cuj-Napoca
Florin Bacanu, md
Principal Investigator
Sf Maria Clinical Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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