Cystic Fibrosis Clinical Trial
Official 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.
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.
This prospective study will try to identify venous thrombosis whatever they are -
symptomatic or silent - and to identify the genetic and acquired risk factors, the
circumstances of occurrence and the current therapeutic modalities. Furthermore, the setting
up of an early treatment on still asymptomatic thrombosis allows the researchers to hope for
a prompt resolution of the thrombosis.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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