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A Prospective Study About Complications of Totally Implantable Central Venous Access Ports in People With CF


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N/A
N/A
Not Enrolling
Both
Cystic Fibrosis

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Trial Information

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


Inclusion Criteria:



- 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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

Italy: Ethics Committee

Study ID:

FFC#30/2008

NCT ID:

NCT00670579

Start Date:

May 2008

Completion Date:

September 2010

Related Keywords:

  • Cystic Fibrosis
  • TIVAD
  • complications
  • nursing
  • cystic fibrosis
  • implanted
  • Cystic Fibrosis
  • Fibrosis

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