Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
This study has been terminated.
(Sponsor stopped due to difficulties to recruit 402 patients required by protocol)
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborator:
Laboratorio farmacéutico ROVI
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00311896
First received: April 5, 2006
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Thrombosis |
Drug: Bemiparin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:
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.
| Enrollment: | 402 |
| Study Start Date: | July 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bemiparin | Drug: Bemiparin |
| Placebo Comparator: Placebo | Drug: Placebo |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311896
Locations
| Romania | |
| 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 | |
| Spain | |
| 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, Spain, 46009 | |
| Hospital Universitario Doctor Peset | |
| Valencia, Spain | |
| Hospital Clinico Universitario Lozano Blesa | |
| Zaragoza, Spain, 50009 | |
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
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 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 | HOSPITAL GERMANS TRIAS I PUJOL |
| Principal Investigator: | Carmen Arratibel, MD | Complejo Hospitalario de Donostia |
| Principal Investigator: | Francisco J. Capote, MD | Hospital 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 Universitario Río Hortega |
| Principal Investigator: | Carmen Sedano, MD | Hospital Marqués de Valdecilla |
| Principal Investigator: | Natividad Gómez, MD | Hospital Universitario de la Princesa |
| Principal Investigator: | Amalia Velasco, MD | 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 |
More Information
No publications provided
| Responsible Party: | Clinica Universidad de Navarra, Universidad de Navarra |
| ClinicalTrials.gov Identifier: | NCT00311896 History of Changes |
| Other Study ID Numbers: | ICT-BEM-2004-02, BECAT |
| Study First Received: | April 5, 2006 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
|
Cancer Thrombosis Catheter Bemiparin Prophylaxis |
Additional relevant MeSH terms:
|
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013