Cystic Fibrosis and Totally Implantable Vascular Access Devices (RITHM)

• ClinicalTrials.gov Identifier: NCT00244270
• Recruitment Status: Completed
• First Posted: October 26, 2005
• Last Update Posted: August 29, 2011
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Vaincre la Mucoviscidose
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cystic Fibrosis; Venous Thrombosis	Device: totally implantable vascular access device	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• 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
• Study Start Date: December 2005
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; totally implantable vascular access device	Device: totally implantable vascular access device; totally implantable vascular access device

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

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
• Other Study ID Numbers: P041202
• 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:

Cystic Fibrosis; Thrombosis; Venous Thrombosis; Fibrosis; 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