A Prospective Study About Complications of Totally Implantable Central Venous Access Ports in People With CF
To be included in the study, subjects need to fulfil the following requirements:
- Diagnosis of CF, made accordingly to the CF Foundation Guideline;
- Ability to consciously express owns informed consent, if aged 18 or more. If minor,
presence of at least one legally authorised parent able to consciously express informed
consent;
- Have a TIVAD implanted;
- Have no current complications in the TIVAD (infection, thromboembolic complications or
occlusion) Outcome Measures
Measured outcomes will be:
1. Incidence of TIVAD infections (Port pocket infection, Cutaneous site
infection,Catheter-related infection;
2. Incidence of TIVAD thrombosis;
3. Incidence of TIVAD occlusion.
The observational phase will last 12 months for each subject involved
Observational
Observational Model: Cohort, Time Perspective: Prospective
To determine the incidence of late complications (infectious, thrombotic and obstructive) in CF people with a totally implanted venous access devices and to investigate possible associations between the onset of complications and several variables
12 months
No
Italy: Ethics Committee
FFC#30/2008
NCT00670579
May 2008
September 2010
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