Cystic Fibrosis and Totally Implantable Vascular Access Devices (RITHM)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis Venous Thrombosis |
Device: totally implantable vascular access device |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
- There is no primary outcome measure specified for this study. [ Time Frame: during de study ] [ Designated as safety issue: Yes ]There is no primary outcome measure specified for this study.
| Enrollment: | 97 |
| Study Start Date: | December 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
totally implantable vascular access device
|
Device: totally implantable vascular access device
totally implantable vascular access device
Other Name: totally implantable vascular access device
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00244270 History of Changes |
| Other Study ID Numbers: | P041202 |
| Study First Received: | October 25, 2005 |
| Last Updated: | August 26, 2011 |
| Health Authority: | France: Direction Générale de la Santé |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
totally implantable vascular access devices thromboembolism genetic susceptibility to venous thrombosis. |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Thrombosis Venous Thrombosis Venous Thromboembolism Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thromboembolism |
ClinicalTrials.gov processed this record on June 18, 2013