Cystic Fibrosis Clinical Trial
— RITHMOfficial title:
Cystic Fibrosis and Totally Implantable Vascular Access Devices: Evaluation of the Incidence of Venous Thrombosis Related to the Catheter and Study of the Genetic and Acquired Risk Factors
The purpose of this study is to evaluate the incidence of venous thrombosis occurring on
totally implantable vascular access devices in cystic fibrosis patients who need a new
device (it can be the first one or a subsequent one) and to study the genetic risk factors
of thrombosis adjusted to the acquired ones.
It is a nationwide cohort study planned for two years with a six month follow up period. The
expected number of inclusion is 50 patients each year, that is to say 100 for the whole
study.
In cystic fibrosis, pulmonary exacerbations necessitate repeated intravenous antibiotics,
but the peripheral blood accesses become precarious with time, leading to the indication of
a central venous device. It is important to take a lot of precautions to protect vascular
access. This allows the patient to have a dramatic improvement in life expectancy with such
life-long devices (ONM, French National Observatory France 2003 : median at 36 years).
Venous thrombosis can cause a superior cava syndrome, a pleural effusion or a pulmonary
embolism. The risk of thrombosis is significant; retrospectively, it has been evaluated to
be between 4 and 16% in the publications. This rate may be higher due to the fact that
venous thrombosis may remain asymptomatic, and therefore silent, but they lead to the same
risk of vascular access loss.
Status | Completed |
Enrollment | 97 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Children or adults with cystic fibrosis (identified either by 2 abnormal sweat tests and/or two CFTR [cystic fibrosis transmembrane conductance regulator] mutations) who need a totally implantable vascular access device. - Signed informed consent Exclusion Criteria: - Refusal of participation in the study - Patients on a waiting list for pulmonary or hepatic transplantation - Patients who received a pulmonary or hepatic graft |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | There is no primary outcome measure specified for this study. | There is no primary outcome measure specified for this study. | during de study | Yes |
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