This study aims at evaluating 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 cures 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 the vascular access allowing the patient to have such devices all life long accordingly with the dramatic improvement of life expectancy (ONM, French National Observatory France 2003 : median at 36 years). The venous thrombosis can cause a superior cava venous syndrome, a pleural effusion or a pulmonary embolism. The risk of thrombosis is significant ; retrospectively it has been evaluated between 4 and 16% of the publications. This rate may be higher due to the fact that venous thrombosis may remain asymptomatic and therefore silent but they leed 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 us to hope for a prompt resolution of the thrombosis.

Condition	Intervention	Phase
Cystic Fibrosis Totaly Implantable Vascular Access Device	Device: totaly implantable vascular access device	Phase IV

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

Primary Outcomes: the occurrence of venous thrombosis related to the catheter identified by ultrasonography.
Secondary Outcomes: evaluation of the different risk factors of venous thromboembolism : genetic susceptibility, acquired risk factors, characteristics of the totally implantable device.
Expected Total Enrollment:  100

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Children or adults with cystic fibrosis (identified either by 2 abnormal sweat tests and/or two CFTR mutations) who need a totally implantable vascular access device.
• Signed informed consent

Exclusion Criteria:

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00244270

Study chairs or principal investigators

Anne MUNCK, MD,  Principal Investigator,  Hôpital Robert Debré, APHP, France   

Study ID Numbers:  P041202
Last Updated:  December 8, 2005
Record first received:  October 25, 2005
ClinicalTrials.gov Identifier:  NCT00244270
Health Authority: France : DGS : direction générale de la santé
ClinicalTrials.gov processed this record on 2006-01-10