Spots Global Cancer Trial Database for Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
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Trial Identification
Brief Title: Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
Official Title: 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)
Study ID: NCT00311896
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arad County Hospital, Arad, , Romania
Cenral Emergency Clinical Military H., Bucharest, , Romania
Sf Maria Clinical Hospital, Bucharest, , Romania
Oncology Institute Cuj-Napoca, Cluj-Napoca, , Romania
University "CF" Clinical Hospital, Cluj-Napoca, , Romania
Filantropia District Hospital, Craiova, , Romania
Oncology Medical Center, Iasi, Iasi, , Romania
District Emergency Clinical Hospital, Targu-Mures, , Romania
Hospital General de Alicante, Alicante, , Spain
Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Clínico San Carlos-Madrid., Madrid, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Morales Meseguer, Murcia, , Spain
Clínica Universitaria de Navarra, Pamplona, , Spain
Complejo Hospitalario de Donostia, San Sebastian, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Universitario Doctor Peset, Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: Eduardo Rocha, MD
Affiliation: Clinica Universitaria de Navarra
Role: STUDY_CHAIR
Name: Ramon Lecumberri, MD
Affiliation: Clinica Universitaria de Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Vicente Vicente, MD
Affiliation: Hospital Morales Meseguer
Role: PRINCIPAL_INVESTIGATOR
Name: Pascual Marco, MD
Affiliation: Hospital General Universitario de Alicante
Role: PRINCIPAL_INVESTIGATOR
Name: José Mateo, MD
Affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: Albert Font, MD
Affiliation: Germans Trias i Pujol Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Carmen Arratibel, MD
Affiliation: Complejo Hospitalario de Donostia
Role: PRINCIPAL_INVESTIGATOR
Name: Francisco J. Capote, MD
Affiliation: Hospital Universitario Puerta del Mar
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel Angel De gregorio Ariza, MD
Affiliation: Hospital Clinico Universitario Lozano Blesa-Zaragoza
Role: PRINCIPAL_INVESTIGATOR
Name: Isabel Picón Roig, MD
Affiliation: Instituto Valenciano de Oncología
Role: PRINCIPAL_INVESTIGATOR
Name: Ricardo González Del Val Subirats, MD
Affiliation: Hospital General Universitario Gregorio Marañón
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Bosh Roig, MD
Affiliation: Hospital Universitario Doctor Peset
Role: PRINCIPAL_INVESTIGATOR
Name: Pedro Pérez-Segura, MD
Affiliation: Hospital Clínico San Carlos-Madrid.
Role: PRINCIPAL_INVESTIGATOR
Name: Vicente Alberola, MD
Affiliation: Hospital Arnau de Vilanova de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: César Rodríguez Sánchez, MD
Affiliation: Hospital Clínico de Salamanca
Role: PRINCIPAL_INVESTIGATOR
Name: Ignacio Alberca Silva, MD
Affiliation: Hospital Clínico de Salamanca
Role: PRINCIPAL_INVESTIGATOR
Name: Javier García Frade, MD
Affiliation: Hospital del Río Hortega
Role: PRINCIPAL_INVESTIGATOR
Name: Carmen Sedano, MD
Affiliation: Hospital Marqués de Valdecilla
Role: PRINCIPAL_INVESTIGATOR
Name: Natividad Gómez, MD
Affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Role: PRINCIPAL_INVESTIGATOR
Name: Amalia Velasco, MD
Affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Role: PRINCIPAL_INVESTIGATOR
Name: Carmen Rodríguez Pinto, MD
Affiliation: Hospital Universitario Central de Asturias
Role: PRINCIPAL_INVESTIGATOR
Name: Mihai Ciochinaru, MD
Affiliation: Cenral Emergency Clinical Military H.
Role: PRINCIPAL_INVESTIGATOR
Name: Cornelia Toganel, MD
Affiliation: District Emergency Clinical Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Csaba Bela Szekely, MD
Affiliation: Arad District Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Mihaela Danciulescu, MD
Affiliation: Filantropia District Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Constantin Volovat, MD
Affiliation: Oncology Medical Center Iasi
Role: PRINCIPAL_INVESTIGATOR
Name: Mircea Cazacu, Prof.
Affiliation: University "CF" Clinical Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Eliade Ciuleanu, MD
Affiliation: Oncology Institute Cuj-Napoca
Role: PRINCIPAL_INVESTIGATOR
Name: Florin Bacanu, md
Affiliation: Sf Maria Clinical Hospital
Role: PRINCIPAL_INVESTIGATOR
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