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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 1
totally implantable vascular access device
|
totally implantable vascular access device
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
There is no primary outcome measure specified for this study.
Lasso di tempo: during de study
|
There is no primary outcome measure specified for this study.
|
during de study
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Anne Munck, MD, Hôpital Robert Debré, APHP, France
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P041202
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