Study to Evaluate the Efficacy and Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)

This study is currently recruiting participants.

Verified by Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra, March 2007

First Received: April 5, 2006 Last Updated: March 15, 2007 History of Changes

Sponsors and Collaborators:	Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra Instituto Científico y Tecnológico de Navarra (ICT)
Information provided by:	Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:	NCT00311896

Purpose

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)

Condition	Intervention	Phase
Cancer Thrombosis	Drug: Bemiparin	Phase III

MedlinePlus related topics: Cancer Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra:

Primary Outcome Measures:

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.

Estimated Enrollment:	402
Study Start Date:	July 2005
Estimated Study Completion Date:	March 2007

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311896

Contacts

Contact: Eduardo Rocha, MD

+34948 296 500

erocha@unav.es

Locations

Spain
Clínica Universitaria de Navarra	Recruiting
Pamplona, Spain
Principal Investigator: Ramon Lecumberri, MD
Hospital Morales Meseguer	Recruiting
Murcia, Spain
Principal Investigator: Vicente Vicente, MD
Hospital General de Alicante	Recruiting
Alicante, Spain
Principal Investigator: Pascual Marco, MD
Hospital Puerta del Mar	Not yet recruiting
Cadiz, Spain
Principal Investigator: Francisco J. Capote, MD
Hospital Santa Creu i Sant Pau	Recruiting
Barcelona, Spain
Principal Investigator: Jose Mateo, MD
Hospital Germans Trias i Pujol	Recruiting
Barcelona, Spain
Principal Investigator: Albert Font, MD
Complejo Hospitalario de Donostia	Recruiting
San Sebastian, Spain
Principal Investigator: Carmen Arratibel, MD
Spain, Valencia
Instituto Valenciano de Oncología	Not yet recruiting
C/ Prof. Beltrán Báguena, 19, Valencia, Spain, 46009
Contact: Maria Isabel Picón Roig, MD 961114038 hematología@fivo.org
Principal Investigator: Maria Isabel Picón Roig, MD
Spain, Zaragoza
Hospital Clinico Universitario Lozano Blesa	Recruiting
Avd San Juan Bosco 15,Zaragoza, Zaragoza, Spain, 50009
Contact: Miguel Angel De Gregorio Ariza, MD 976765766 ext 2983 mgregori@unizar.es
Principal Investigator: Miguel Angel De Gregorio Ariza, MD

Sponsors and Collaborators

Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra

Instituto Científico y Tecnológico de Navarra (ICT)

Investigators

Study Chair:	Eduardo Rocha, MD	Clinica Universitaria de Navarra
Principal Investigator:	Ramon Lecumberri, MD	Clinica Universitaria de Navarra
Principal Investigator:	Vicente Vicente, MD	Hospital Morales Meseguer
Principal Investigator:	Pascual Marco, MD	Hospital General de Alicante
Principal Investigator:	José Mateo, MD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator:	Albert Font, MD	Hospital Germans Trias i Pujol
Principal Investigator:	Carmen Arratibel, MD	Complejo Hospitalario de Donostia
Principal Investigator:	Francisco J. Capote, MD	Hospital Puerta del Mar
Principal Investigator:	Miguel Angel De gregorio Ariza, MD	Hospital Clinico Universitario Lozano Blesa-Zaragoza
Principal Investigator:	Maria Isabel Picón Roig, MD	Instituto Valenciano de Oncología

More Information

No publications provided

Study ID Numbers:	ICT-BEM-2004-02, BECAT
Study First Received:	April 5, 2006
Last Updated:	March 15, 2007
ClinicalTrials.gov Identifier:	NCT00311896 History of Changes
Health Authority:	Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra:

Cancer
Thrombosis
Catheter
Bemiparin
Prophylaxis

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 07, 2009