Cancer patients with totally implantable vascular access device
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Heparin
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Solution
Sponsors
AZIENDA SANITARIA LOCALE BI DI BIELLA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Oncohaematology or cancer patients (except leukemia),candidate to receive chemotherapy intravenously, with an estimated survival of more than 3 months; Presence of a ``Port`` with a catheter open-ended (planted not later than 45 days, not previously used for administration of therapy); Age >= 18 years; Performance Status Kornofsky: 100-60; Patient able to read, understand and provide the required informed consent for participation in the study. 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 leukemia disease; Patients with ``port`` complications; Patients with previous events of system failure before recruitment; Performance Status Kornofsky <60; Patients whith ``port`` used for administration of parenteral nutrition with lipids; Patients with known or suspected heparin intolerance/allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of ``port`` occlusion incidence connected to the different types of flushing;Secondary Objective: Assessment of relationship between costs and efficacy of two types of flushing; Assessment of port infections incidence connected to the type of flushing; Assessement of other not−infectious complications incidence of the ``port`` connected to the type of flushing;Primary end point(s): Main outcome: ``Port`` failure for lumen occlusion | — |
Countries
Italy
Outcome results
None listed