Hemotrial Un proyecto de SEHH

Ensayo clínico

Multicenter double-blind placebo controlled aleatorized study to evaluate the efficacy and safety of bemiparin (3500 IU/day) in thromboprophylaxis in cancer paients with central vein catheter

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Multicenter double-blind placebo controlled aleatorized study to evaluate the efficacy and safety of bemiparin (3500 IU/day) in thromboprophylaxis in cancer paients with central vein catheter


Resumen

2017-03-15 03:56:34
2004-004826-28
ict-bem-2004-02
Multicenter double-blind placebo controlled aleatorized study to evaluate the efficacy and safety of bemiparin (3500 IU/day) in thromboprophylaxis in cancer paients with central vein catheter
Becat
ict-bem-2004-02

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
Instituto Científico y Tecnológico de Navarra Spain

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test Hibor 3500 antiXA IU/day
Laboratorio Farmaceutico Rovi S.A
Solution for injection
Subcutaneous use

Detalles del Fármaco (Principio Activo):

Concentración del fármaco:

IU internationa equal

3500

Contenido del fármaco


Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

Information no disponible en EudraCT
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Solution for injection

Subcutaneous use

Información General



Enfermedad Trombótica

Deep Vein Thrombosis related central vein catheter (DVT-CVC)


To asses the efficacy and safety of bemiparin in the prevention of deep vein thrombosis in cancer patients with central vein catheter (CVC)


Information no disponible en EudraCT


Males and females patients at least 18 years old; Cancer patients; Patients with current value of platelet > 30.000/mm3; Patients without bleeding symptomatology

Patients with previous bleeding episodes and / or high risk of blood loss (due to any change in haemostasis) and/or patients with active haemorrhage and organic lesions that are likely to bled within last two months; Major surgery within last month; Patients, with known hypersensitivity reactions to LWHs, heparin or any substances of porcine origin;Patients with congenital or acquired bleeding diathesis; Eye, ear and central nervous system damages or surgeries within the last 6 months; Acute bacterial endocarditis and slow endocarditis; Patients with history of heparin-induced thrombocytopenia; Patients with severe renal impairment (serum creatinine> 2 mg/dl) or severe impairment of liver (AST and/ or ALT levels more than five times the normal limit according to the locals laboratory ranges); Acute arterial hypertension (Systolic arterial hypertension> 200 mmHg and/ or diastolic arterial hypertension >120 mmHg); Suspected patients or patients unable to carry out the treatment or to follow up the study; Patients who have been enrolled in another clinical trial in the past 30 days, or patients who are currently enrolled in another CT;Life expectancy of less than three months; Pregnant or lactating women and women of child-bearing potential; Current anticoagulant therapy or anticoagulant treatment within the week prior to the CVC insertion; Diagnosed patients with acute leukaemia or patients who are going to undergo a haematopoietic progenitor transplantation during the 90 study´s days

Composite incidence during the treatment period of:•Clinical and symptomatic Deep Vein Thrombosis related Central Vein Catheter checked by objective testing(Doppler ecography or flebography)•Subclinical or asymptomatic DVT-CVC confirmed by bilateral elective Doppler ecography in the day 45 ± 5 after the aleatorization.

Fase III
  DISEÑO DEL ENSAYO:

Si
Si

No
No

Si
Si

No
No
  COMPARADOR DEL ENSAYO CONTROLADO:

No
Si

No
No

Si

Centros participantes:


No
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

0
9
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:


0
1

1

Sexo:


1
1

Número planeado de pacientes a incluir:


402

Para estudios internacionales:



Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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