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

Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00311896
• Other study ID #: ICT-BEM-2004-02
• Secondary ID: BECAT
• Status: Terminated
• Phase: Phase 3
• First received: April 5, 2006
• Last updated: June 7, 2012
• Start date: July 2005
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 402
• Est. completion date: December 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Thrombosis

Intervention

Drug:
• Bemiparin

• Placebo

Locations

Country	Name	City	State
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
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	Hospital Universitario Doctor Peset	Valencia
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Laboratorio farmacéutico ROVI

Countries where clinical trial is conducted

Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
Primary	Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.