Back to resultsEfficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
Primary Purpose
Cancer, Thrombosis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bemiparin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cancer focused on measuring Cancer, Thrombosis, Catheter, Bemiparin, Prophylaxis
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.
Sites / Locations
- Arad County Hospital
- Cenral Emergency Clinical Military H.
- Sf Maria Clinical Hospital
- Oncology Institute Cuj-Napoca
- University "CF" Clinical Hospital
- Filantropia District Hospital
- Oncology Medical Center, Iasi
- District Emergency Clinical Hospital
- Hospital General de Alicante
- Hospital Germans Trias i Pujol
- Hospital Santa Creu i Sant Pau
- Hospital Clínico San Carlos-Madrid.
- Hospital General Universitario Gregorio Marañón
- Hospital Morales Meseguer
- Clínica Universitaria de Navarra
- Complejo Hospitalario de Donostia
- Instituto Valenciano de Oncología
- Hospital Universitario Doctor Peset
- Hospital Clinico Universitario Lozano Blesa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bemiparin
Placebo
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00311896
First Posted
April 5, 2006
Last Updated
June 7, 2012
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Laboratorio farmacéutico ROVI
1. Study Identification
Unique Protocol Identification Number
NCT00311896
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Sponsor stopped due to difficulties to recruit 402 patients required by protocol
Study Start Date
July 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Laboratorio farmacéutico ROVI
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Thrombosis
Keywords
Cancer, Thrombosis, Catheter, Bemiparin, Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bemiparin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bemiparin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
Title
Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Rocha, MD
Organizational Affiliation
Clinica Universitaria de Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ramon Lecumberri, MD
Organizational Affiliation
Clinica Universitaria de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vicente Vicente, MD
Organizational Affiliation
Hospital Morales Meseguer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascual Marco, MD
Organizational Affiliation
Hospital General Universitario de Alicante
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Mateo, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert Font, MD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmen Arratibel, MD
Organizational Affiliation
Complejo Hospitalario de Donostia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco J. Capote, MD
Organizational Affiliation
Hospital Universitario Puerta del Mar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miguel Angel De gregorio Ariza, MD
Organizational Affiliation
Hospital Clinico Universitario Lozano Blesa-Zaragoza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabel Picón Roig, MD
Organizational Affiliation
Instituto Valenciano de Oncología
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo González Del Val Subirats, MD
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Bosh Roig, MD
Organizational Affiliation
Hospital Universitario Doctor Peset
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro Pérez-Segura, MD
Organizational Affiliation
Hospital Clínico San Carlos-Madrid.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vicente Alberola, MD
Organizational Affiliation
Hospital Arnau de Vilanova de Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
César Rodríguez Sánchez, MD
Organizational Affiliation
Hospital Clínico de Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ignacio Alberca Silva, MD
Organizational Affiliation
Hospital Clínico de Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier García Frade, MD
Organizational Affiliation
Hospital del Río Hortega
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmen Sedano, MD
Organizational Affiliation
Hospital Marqués de Valdecilla
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natividad Gómez, MD
Organizational Affiliation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amalia Velasco, MD
Organizational Affiliation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmen Rodríguez Pinto, MD
Organizational Affiliation
Hospital Universitario Central de Asturias
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mihai Ciochinaru, MD
Organizational Affiliation
Cenral Emergency Clinical Military H.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cornelia Toganel, MD
Organizational Affiliation
District Emergency Clinical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Csaba Bela Szekely, MD
Organizational Affiliation
Arad District Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mihaela Danciulescu, MD
Organizational Affiliation
Filantropia District Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Constantin Volovat, MD
Organizational Affiliation
Oncology Medical Center Iasi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mircea Cazacu, Prof.
Organizational Affiliation
University "CF" Clinical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eliade Ciuleanu, MD
Organizational Affiliation
Oncology Institute Cuj-Napoca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florin Bacanu, md
Organizational Affiliation
Sf Maria Clinical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arad County Hospital
City
Arad
Country
Romania
Facility Name
Cenral Emergency Clinical Military H.
City
Bucharest
Country
Romania
Facility Name
Sf Maria Clinical Hospital
City
Bucharest
Country
Romania
Facility Name
Oncology Institute Cuj-Napoca
City
Cluj-Napoca
Country
Romania
Facility Name
University "CF" Clinical Hospital
City
Cluj-Napoca
Country
Romania
Facility Name
Filantropia District Hospital
City
Craiova
Country
Romania
Facility Name
Oncology Medical Center, Iasi
City
Iasi
Country
Romania
Facility Name
District Emergency Clinical Hospital
City
Targu-Mures
Country
Romania
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico San Carlos-Madrid.
City
Madrid
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Complejo Hospitalario de Donostia
City
San Sebastian
Country
Spain
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
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