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

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra (Other)

Overall Status

Terminated

CT.gov ID

NCT00311896

Collaborator

Laboratorio farmacéutico ROVI (Other)

402

Enrollment

Locations

Arms

Duration (Months)

21.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Cancer Thrombosis	Drug: Bemiparin Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

402 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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)

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bemiparin	Drug: Bemiparin
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Bemiparin

Drug: Bemiparin

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Arad County Hospital	Arad	Romania
2	Cenral Emergency Clinical Military H.	Bucharest	Romania
3	Sf Maria Clinical Hospital	Bucharest	Romania
4	Oncology Institute Cuj-Napoca	Cluj-Napoca	Romania
5	University "CF" Clinical Hospital	Cluj-Napoca	Romania
6	Filantropia District Hospital	Craiova	Romania
7	Oncology Medical Center, Iasi	Iasi	Romania
8	District Emergency Clinical Hospital	Targu-Mures	Romania
9	Hospital General de Alicante	Alicante	Spain
10	Hospital Germans Trias i Pujol	Barcelona	Spain
11	Hospital Santa Creu i Sant Pau	Barcelona	Spain
12	Hospital Clínico San Carlos-Madrid.	Madrid	Spain
13	Hospital General Universitario Gregorio Marañón	Madrid	Spain
14	Hospital Morales Meseguer	Murcia	Spain
15	Clínica Universitaria de Navarra	Pamplona	Spain
16	Complejo Hospitalario de Donostia	San Sebastian	Spain
17	Instituto Valenciano de Oncología	Valencia	Spain	46009
18	Hospital Universitario Doctor Peset	Valencia	Spain
19	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 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 Río 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