Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study

Completed

• Conditions: Cancer

• Registration Number: NCT02025894
• Lead Sponsor: Institut de Cancérologie de la Loire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Status Verified: 2013-12
• Study First Submitted: 2013-12-31
• Study First Submitted QC: 2013-12-31
• Study First Posted: 2014-01-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3032

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thromboembolic complications:	one year
Locoregional or disseminated infectious complications:	one year

Secondary Outcome Measures

Name	Time	Method
Medical and economic consequences of these complications	one year

Trial Locations

Locations (27)

CH Intercommunal Annemasse-Bonneville; 🇫🇷 Annemasse, France

Institut Daniel Hollard; 🇫🇷 Grenoble, France

Hôpital Desgenettes; 🇫🇷 Lyon, France

CH Pays du Gier; 🇫🇷 Saint-Chamond, France

Hôpitaux du Léman; 🇫🇷 Thonon-les-bains, France

Polyclinique de Savoie; 🇫🇷 Annemasse, France

CH d'Annecy; 🇫🇷 Annecy, France

CH Chambéry; 🇫🇷 Chambéry, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Pôle Santé république; 🇫🇷 Clermont-Ferrand, France

CH Feurs; 🇫🇷 Feurs, France

CH de Montbrison; 🇫🇷 Montbrison, France

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

CH EmileRoux; 🇫🇷 Le Puy en Velay, France

Hôpital privé de la Loire; 🇫🇷 Saint-Etienne, France

Clinique de la sauvergarde; 🇫🇷 Lyon, France

Hôpital Privé Drôme Ardèche; 🇫🇷 Valence, France

Clinique Eugène André; 🇫🇷 Lyon, France

CH Lyon Sud; 🇫🇷 Lyon, France

Clinique Portes du Sud; 🇫🇷 Lyon, France

Clinique Saint-Joseph Saint-Luc; 🇫🇷 Lyon, France

CHU Saint-Etienne Service de Gastroentérologie; 🇫🇷 Saint-Etienne, France

CHU Saint-Etienne Service de Gynécologie; 🇫🇷 Saint-Etienne, France

Hôpital privé Jean-Mermoz; 🇫🇷 Lyon, France

Infirmerie Protestante; 🇫🇷 Lyon, France

CH de Roanne; 🇫🇷 Roanne, France

Institut Cancérologique Lucien neuwirth; 🇫🇷 Saint Priest en Jarez, France