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
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |