TerminatedNCT00311896Updated Jun 8, 2012

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

A Phase 3 interventional study of Bemiparin and Placebo in Cancer and Thrombosis, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Terminated at 19 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-08.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Phase 3, Interventional, and Prevention

Why this study was terminated

Sponsor stopped due to difficulties to recruit 402 patients required by protocol

Phase: Phase 3
Study type: Interventional
Enrollment: 402
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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)

Read the 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.

Conditions studied

Cancer
Thrombosis

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Thrombosis 1,506

Keywords

Cancer
Thrombosis
Catheter
Bemiparin
Prophylaxis

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 402 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 402 participants (actual)

Study arms

Experimental
Bemiparin
Drug: Bemiparin
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugBemiparin
DrugPlacebo

What researchers measure

Primary outcomes

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.

Study locations

19 sites

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
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, 46009, Spain
Hospital Universitario Doctor Peset
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00311896
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Collaborators: Laboratorio farmacéutico ROVI
Responsible party: Sponsor
First posted: Apr 6, 2006
Start date: Jul 2005
Primary completion: Feb 2009
Completion: Dec 2010
Last update: Jun 8, 2012

Study contacts

Eduardo Rocha, MD

study chair · Clinica Universitaria de Navarra

Ramon Lecumberri, MD

principal investigator · Clinica Universitaria de Navarra

Vicente Vicente, MD

principal investigator · Hospital Morales Meseguer

Pascual Marco, MD

principal investigator · Hospital General Universitario de Alicante

José Mateo, MD

principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Albert Font, MD

principal investigator · Germans Trias i Pujol Hospital

Carmen Arratibel, MD

principal investigator · Complejo Hospitalario de Donostia

Francisco J. Capote, MD

principal investigator · Hospital Universitario Puerta del Mar

Miguel Angel De gregorio Ariza, MD

principal investigator · Hospital Clinico Universitario Lozano Blesa-Zaragoza

Isabel Picón Roig, MD

principal investigator · Instituto Valenciano de Oncología

Ricardo González Del Val Subirats, MD

principal investigator · Hospital General Universitario Gregorio Marañón

Carlos Bosh Roig, MD

principal investigator · Hospital Universitario Doctor Peset

Pedro Pérez-Segura, MD

principal investigator · Hospital Clínico San Carlos-Madrid.

Vicente Alberola, MD

principal investigator · Hospital Arnau de Vilanova de Valencia

César Rodríguez Sánchez, MD

principal investigator · Hospital Clínico de Salamanca

Ignacio Alberca Silva, MD

principal investigator · Hospital Clínico de Salamanca

Javier García Frade, MD

principal investigator · Hospital del Rio Hortega

Carmen Sedano, MD

principal investigator · Hospital Marqués de Valdecilla

Natividad Gómez, MD

principal investigator · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Amalia Velasco, MD

principal investigator · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Carmen Rodríguez Pinto, MD

principal investigator · Hospital Universitario Central de Asturias

Mihai Ciochinaru, MD

principal investigator · Cenral Emergency Clinical Military H.

Cornelia Toganel, MD

principal investigator · District Emergency Clinical Hospital

Csaba Bela Szekely, MD

principal investigator · Arad District Hospital

Mihaela Danciulescu, MD

principal investigator · Filantropia District Hospital

Constantin Volovat, MD

principal investigator · Oncology Medical Center Iasi

Mircea Cazacu, Prof.

principal investigator · University "CF" Clinical Hospital

Eliade Ciuleanu, MD

principal investigator · Oncology Institute Cuj-Napoca

Florin Bacanu, md

principal investigator · Sf Maria Clinical Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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