Deep Vein Thrombosis related central vein catheter (DVT-CVC) MedDRA version: 7.1 Level: LLT Classification code 10051055
Conditions
Interventions
Trade Name: Hibor 3500 antiXA IU/day
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bemiparin sodium
Concentration unit: IU international unit(s)
Concentration type: equal
Concentrat
Sponsors
Instituto Científico y Tecnológico de Navarra
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females patients at least 18 years old; Cancer patients; Patients with current value of platelet > 30.000/mm3; Patients without bleeding symptomatology Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses the efficacy and safety of bemiparin in the prevention of deep vein thrombosis in cancer patients with central vein catheter (CVC);Secondary Objective: ;Primary end point(s): 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. | — |
Countries
Spain
Outcome results
None listed