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

NCT00311896 | Terminated Phase 3

• 2 other identifiers: ICT-BEM-2004-02BECAT
• Study Type: interventional
• Target: 402
• Locations: 2 countries
• Sites: 19

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)

Conditions

Cancer; Thrombosis

Keywords

Cancer; Thrombosis; Catheter; Bemiparin; Prophylaxis

Outcome Measures

Primary Outcomes (2)

• 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 Arms (2)

Bemiparin

EXPERIMENTAL

Drug: Bemiparin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Bemiparin DRUG

Bemiparin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Laboratorio farmacéutico ROVI: collaborator

Study Sites (19)

Arad County Hospital

Arad, Romania

Location

Cenral Emergency Clinical Military H.

Bucharest, Romania

Location

Sf Maria Clinical Hospital

Bucharest, Romania

Location

Oncology Institute Cuj-Napoca

Cluj-Napoca, Romania

Location

University "CF" Clinical Hospital

Cluj-Napoca, Romania

Location

Filantropia District Hospital

Craiova, Romania

Location

Oncology Medical Center, Iasi

Iași, Romania

Location

District Emergency Clinical Hospital

Târgu Mureş, Romania

Location

Hospital General de Alicante

Alicante, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Location

Complejo Hospitalario de Donostia

Donostia / San Sebastian, Spain

Location

Hospital Clínico San Carlos-Madrid.

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Morales Meseguer

Murcia, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Universitario Doctor Peset

Valencia, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Neoplasms; Thrombosis

Interventions

bemiparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eduardo Rocha, MD

  Clinica Universitaria de Navarra

  STUDY CHAIR

• 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 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 del Rio Hortega

  PRINCIPAL INVESTIGATOR

• Carmen Sedano, MD

  Hospital Marqués 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Study Start: July 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: December 1, 2010
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

RO (8); ES (11)