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Cystic Fibrosis and Totally Implantable Vascular Access Devices (RITHM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244270
First Posted: October 26, 2005
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vaincre la Mucoviscidose
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • There is no primary outcome measure specified for this study. [ Time Frame: during de study ]
    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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244270


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Vaincre la Mucoviscidose
Investigators
Principal Investigator: Anne Munck, MD Hôpital Robert Debré, APHP, France
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00244270     History of Changes
Other Study ID Numbers: P041202
First Submitted: October 25, 2005
First Posted: October 26, 2005
Last Update Posted: August 29, 2011
Last Verified: September 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
totally implantable vascular access devices
thromboembolism
genetic susceptibility to venous thrombosis.

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Thrombosis
Venous Thrombosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases


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