Clinical trial NCT00311896: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer
Thrombosis
Keywords: Cancer
Thrombosis
Catheter
Bemiparin
Prophylaxis
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Laboratorio farmacéutico ROVI
First posted: 2006-04-06
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Primary outcomes:
measure: Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
measure: Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
Secondary outcomes:
Other outcomes:
Locations:
city: Arad
country: Romania
facility: Arad County Hospital
city: Bucharest
country: Romania
facility: Cenral Emergency Clinical Military H.
city: Bucharest
country: Romania
facility: Sf Maria Clinical Hospital
city: Cluj-Napoca
country: Romania
facility: Oncology Institute Cuj-Napoca
city: Cluj-Napoca
country: Romania
facility: University "CF" Clinical Hospital
city: Craiova
country: Romania
facility: Filantropia District Hospital
city: Iasi
country: Romania
facility: Oncology Medical Center, Iasi
city: Targu-Mures
country: Romania
facility: District Emergency Clinical Hospital
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos-Madrid.
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: San Sebastian
country: Spain
facility: Complejo Hospitalario de Donostia
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
Study officials:
affiliation: Clinica Universitaria de Navarra
name: Eduardo Rocha, MD
role: STUDY_CHAIR
affiliation: Clinica Universitaria de Navarra
name: Ramon Lecumberri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Morales Meseguer
name: Vicente Vicente, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Alicante
name: Pascual Marco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: José Mateo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Albert Font, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario de Donostia
name: Carmen Arratibel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta del Mar
name: Francisco J. Capote, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico Universitario Lozano Blesa-Zaragoza
name: Miguel Angel De gregorio Ariza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Valenciano de Oncología
name: Isabel Picón Roig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Gregorio Marañón
name: Ricardo González Del Val Subirats, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Doctor Peset
name: Carlos Bosh Roig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico San Carlos-Madrid.
name: Pedro Pérez-Segura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Arnau de Vilanova de Valencia
name: Vicente Alberola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Salamanca
name: César Rodríguez Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Salamanca
name: Ignacio Alberca Silva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Rio Hortega
name: Javier García Frade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Marqués de Valdecilla
name: Carmen Sedano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Natividad Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Amalia Velasco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Central de Asturias
name: Carmen Rodríguez Pinto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cenral Emergency Clinical Military H.
name: Mihai Ciochinaru, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: District Emergency Clinical Hospital
name: Cornelia Toganel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arad District Hospital
name: Csaba Bela Szekely, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Filantropia District Hospital
name: Mihaela Danciulescu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncology Medical Center Iasi
name: Constantin Volovat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University "CF" Clinical Hospital
name: Mircea Cazacu, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncology Institute Cuj-Napoca
name: Eliade Ciuleanu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sf Maria Clinical Hospital
name: Florin Bacanu, md
role: PRINCIPAL_INVESTIGATOR
References: