Clinical trial NCT02025894: Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study
Official title: Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: neoplastic solid tumour
PCVC
thromboembolic complications
infectious complications
risk factors
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 3032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cohort of consecutive patients

Brief summary: The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.


Eligibility criteria: Inclusion Criteria:

* Patient with a neoplastic solid tumour with an indication for insertion of a PCVC.

Exclusion Criteria:

* Haematological neoplasm pathology, PCVC removal scheduled within 2 weeks of insertion,
* Therapeutic doses of anticoagulants required at inclusion,
* PCVC inserted by the femoral vein

Primary outcomes:
measure: Thromboembolic complications:
timeFrame: one year
measure: Locoregional or disseminated infectious complications:
timeFrame: one year
Secondary outcomes:
measure: Medical and economic consequences of these complications
timeFrame: one year
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH d'Annecy
city: Annemasse
country: France
facility: CH Intercommunal Annemasse-Bonneville
city: Annemasse
country: France
facility: Polyclinique de Savoie
city: Chambéry
country: France
facility: CH Chambéry
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: Pôle Santé république
city: Feurs
country: France
facility: CH Feurs
city: Grenoble
country: France
facility: Institut Daniel Hollard
city: Le Puy en Velay
country: France
facility: CH EmileRoux
city: Lyon
country: France
facility: CH Lyon Sud
city: Lyon
country: France
facility: Clinique de la sauvergarde
city: Lyon
country: France
facility: Clinique Eugène André
city: Lyon
country: France
facility: Clinique Portes du Sud
city: Lyon
country: France
facility: Clinique Saint-Joseph Saint-Luc
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpital Desgenettes
city: Lyon
country: France
facility: Hôpital privé Jean-Mermoz
city: Lyon
country: France
facility: Infirmerie Protestante
city: Montbrison
country: France
facility: CH de Montbrison
city: Roanne
country: France
facility: CH de Roanne
city: Saint Priest en Jarez
country: France
facility: Institut Cancérologique Lucien neuwirth
city: Saint-Chamond
country: France
facility: CH Pays du Gier
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne Service de Gynécologie
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne Service de Gastroentérologie
city: Saint-Etienne
country: France
facility: Hôpital privé de la Loire
city: Thonon-les-bains
country: France
facility: Hôpitaux du Léman
city: Valence
country: France
facility: Hôpital Privé Drôme Ardèche
Study officials:
affiliation: Institut Cancérologique Lucien Neuwirth
name: Pierre Fournel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC - CHU DE SAINT-ETIENNE
name: Hervé DECOUSUS, MDPhD
role: STUDY_DIRECTOR
affiliation: Institut cancérologique Lucien Neuwirth
name: Franck CHAUVIN, MDPhD
role: STUDY_DIRECTOR
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