Cystic Fibrosis and Totally Implantable Vascular Access Devices

NCT00244270 | Completed Phase 4

• 1 other identifier: P041202
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis; Venous Thrombosis

Keywords

totally implantable vascular access devices; thromboembolism; genetic susceptibility to venous thrombosis.

Outcome Measures

Primary Outcomes (1)

• There is no primary outcome measure specified for this study.

  There is no primary outcome measure specified for this study.

  during de study

Study Arms (1)

1

EXPERIMENTAL

totally implantable vascular access device

Device: totally implantable vascular access device

Interventions

totally implantable vascular access device DEVICE

totally implantable vascular access device

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal of participation in the study
• Patients on a waiting list for pulmonary or hepatic transplantation
• Patients who received a pulmonary or hepatic graft

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Vaincre la Mucoviscidose: collaborator

MeSH Terms

Conditions

Cystic Fibrosis; Venous Thrombosis; Thromboembolism

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anne Munck, MD

  Hôpital Robert Debré, APHP, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 26, 2005
• Study Start: December 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 29, 2011

Record last verified: 2005-09