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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


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.
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