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

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)

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)

Study Overview

• Status: Terminated
• Conditions: Cancer; Thrombosis
• Intervention / Treatment: Drug: Placebo; Drug: Bemiparin

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.

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Arad, Romania
    • Arad County Hospital
  • Bucharest, Romania
    • Cenral Emergency Clinical Military H.
  • Bucharest, Romania
    • Sf Maria Clinical Hospital
  • Cluj-Napoca, Romania
    • Oncology Institute Cuj-Napoca
  • Cluj-Napoca, Romania
    • University "CF" Clinical Hospital
  • Craiova, Romania
    • Filantropia District Hospital
  • Iasi, Romania
    • Oncology Medical Center, Iasi
  • Targu-Mures, Romania
    • District Emergency Clinical Hospital
• Spain
  • Alicante, Spain
    • Hospital General de Alicante
  • Barcelona, Spain
    • Hospital Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital Germans Trias i Pujol
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain
    • Hospital Clínico San Carlos-Madrid.
  • Murcia, Spain
    • Hospital Morales Meseguer
  • Pamplona, Spain
    • Clinica Universitaria de Navarra
  • San Sebastian, Spain
    • Complejo Hospitalario de Donostia
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Valencia, Spain
    • Hospital Universitario Doctor Peset
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Bemiparin	Drug: Bemiparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: 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 Universitario 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, Germans Trias i Pujol Hospital; Principal Investigator: Carmen Arratibel, MD, Complejo Hospitalario de Donostia; Principal Investigator: Francisco J. Capote, MD, Hospital Universitario 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 Oncologia; 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 del Rio Hortega; Principal Investigator: Carmen Sedano, MD, Hospital Marques de Valdecilla; Principal Investigator: Natividad Gómez, MD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Principal Investigator: Amalia Velasco, MD, Fundación de Investigación Biomédica - 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

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 5, 2006
• First Submitted That Met QC Criteria: April 5, 2006
• First Posted (Estimate): April 6, 2006

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Cancer; Thrombosis; Bemiparin; Prophylaxis; Catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Anticoagulants; Bemiparin
• Other Study ID Numbers: ICT-BEM-2004-02; BECAT