Cystic Fibrosis and Totally Implantable Vascular Access Devices (RITHM)

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.

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis; Cystic Fibrosis
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; totally implantable vascular access device	Device: totally implantable vascular access device; totally implantable vascular access device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
There is no primary outcome measure specified for this study.	There is no primary outcome measure specified for this study.	during de study

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Vaincre la Mucoviscidose
• Investigators: Principal Investigator: Anne Munck, MD, Hôpital Robert Debré, APHP, France

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: October 25, 2005
• First Submitted That Met QC Criteria: October 25, 2005
• First Posted (Estimate): October 26, 2005

Study Record Updates

• Last Update Posted (Estimate): August 29, 2011
• Last Update Submitted That Met QC Criteria: August 26, 2011
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: thromboembolism; totally implantable vascular access devices; genetic susceptibility to venous thrombosis.
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Embolism and Thrombosis; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: P041202