Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)

This study has been terminated.
(Sponsor stopped due to difficulties to recruit 402 patients required by protocol)
Sponsor:
Collaborator:
Laboratorio farmacéutico ROVI
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00311896
First received: April 5, 2006
Last updated: June 7, 2012
Last verified: June 2012
  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
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Clinica Universidad 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.

Enrollment: 402
Study Start Date: July 2005
Study Completion Date: December 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bemiparin Drug: Bemiparin
Placebo Comparator: Placebo Drug: Placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Romania
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
Spain
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, 46009
Hospital Universitario Doctor Peset
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Laboratorio farmacéutico ROVI
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: Isabel Picón Roig, MD Instituto Valenciano de Oncología
Principal Investigator: Ricardo González Del Val Subirats, MD Hospital General Universitario Gregorio Marañón
Principal Investigator: Carlos Bosh Roig, MD Hospital Universitario Doctor Peset
Principal Investigator: Pedro Pérez-Segura, MD Hospital Clínico San Carlos-Madrid.
Principal Investigator: Vicente Alberola, MD Hospital Arnau de Vilanova de Valencia
Principal Investigator: César Rodríguez Sánchez, MD Hospital Clínico de Salamanca
Principal Investigator: Ignacio Alberca Silva, MD Hospital Clínico de Salamanca
Principal Investigator: Javier García Frade, MD Hospital Universitario Río Hortega
Principal Investigator: Carmen Sedano, MD Hospital Marqués de Valdecilla
Principal Investigator: Natividad Gómez, MD Hospital Universitario de la Princesa
Principal Investigator: Amalia Velasco, MD Hospital Universitario de la Princesa
Principal Investigator: Carmen Rodríguez Pinto, MD Hospital Universitario Central de Asturias
Principal Investigator: Mihai Ciochinaru, MD Cenral Emergency Clinical Military H.
Principal Investigator: Cornelia Toganel, MD District Emergency Clinical Hospital
Principal Investigator: Csaba Bela Szekely, MD Arad District Hospital
Principal Investigator: Mihaela Danciulescu, MD Filantropia District Hospital
Principal Investigator: Constantin Volovat, MD Oncology Medical Center Iasi
Principal Investigator: Mircea Cazacu, Prof. University "CF" Clinical Hospital
Principal Investigator: Eliade Ciuleanu, MD Oncology Institute Cuj-Napoca
Principal Investigator: Florin Bacanu, md Sf Maria Clinical Hospital
  More Information

No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT00311896     History of Changes
Other Study ID Numbers: ICT-BEM-2004-02, BECAT
Study First Received: April 5, 2006
Last Updated: June 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Cancer
Thrombosis
Catheter
Bemiparin
Prophylaxis

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014