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

NCT02025894 | Completed

• 2 other identifiers: 2010-012010-A01064-35
• Study Type: observational
• Target: 3,032
• Locations: 1 country
• Sites: 27

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.

Conditions

Cancer

Keywords

neoplastic solid tumour; PCVC; thromboembolic complications; infectious complications; risk factors

Outcome Measures

Primary Outcomes (2)

• Thromboembolic complications:

  one year

• Locoregional or disseminated infectious complications:

  one year

Secondary Outcomes (1)

• Medical and economic consequences of these complications

  one year

Study Arms (1)

PCVCs

Cohort of cancer patients with indication PCVC under the usual practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cohort of consecutive patients

You may qualify if:

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

You may not qualify if:

• Haematological neoplasm pathology, PCVC removal scheduled within 2 weeks of insertion,
• PCVC inserted by the femoral vein

Sponsors & Collaborators

• Institut de Cancérologie de la Loire: lead

Study Sites (27)

CH d'Annecy

Annecy, France, France

Location

CH Intercommunal Annemasse-Bonneville

Annemasse, France, France

Location

Polyclinique de Savoie

Annemasse, France, France

Location

CH Chambéry

Chambéry, France, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France, France

Location

Pôle Santé république

Clermont-Ferrand, France, France

Location

CH Feurs

Feurs, France, France

Location

Institut Daniel Hollard

Grenoble, France, France

Location

CH EmileRoux

Le Puy-en-Velay, France, France

Location

CH Lyon Sud

Lyon, France, France

Location

Clinique de la sauvergarde

Lyon, France, France

Location

Clinique Eugène André

Lyon, France, France

Location

Clinique Portes du Sud

Lyon, France, France

Location

Clinique Saint-Joseph Saint-Luc

Lyon, France, France

Location

Hôpital de la Croix Rousse

Lyon, France, France

Location

Hôpital Desgenettes

Lyon, France, France

Location

Hôpital privé Jean-Mermoz

Lyon, France, France

Location

Infirmerie Protestante

Lyon, France, France

Location

CH de Montbrison

Montbrison, France, France

Location

CH de Roanne

Roanne, France, France

Location

CH Pays du Gier

Saint-Chamond, France, France

Location

CHU Saint-Etienne Service de Gynécologie

Saint-Etienne, France, 42055, France

Location

CHU Saint-Etienne Service de Gastroentérologie

Saint-Etienne, France, France

Location

Hôpital privé de la Loire

Saint-Etienne, France, France

Location

Institut Cancérologique Lucien neuwirth

Saint-Priest-en-Jarez, France, France

Location

Hôpitaux du Léman

Thonon-les-Bains, France, France

Location

Hôpital Privé Drôme Ardèche

Valence, France, France

Location

Related Publications (9)

• Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

  PMID: 22335737 BACKGROUND

• Debourdeau P, Farge D, Beckers M, Baglin C, Bauersachs RM, Brenner B, Brilhante D, Falanga A, Gerotzafias GT, Haim N, Kakkar AK, Khorana AA, Lecumberri R, Mandala M, Marty M, Monreal M, Mousa SA, Noble S, Pabinger I, Prandoni P, Prins MH, Qari MH, Streiff MB, Syrigos K, Buller HR, Bounameaux H. International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer. J Thromb Haemost. 2013 Jan;11(1):71-80. doi: 10.1111/jth.12071.

  PMID: 23217208 BACKGROUND

• Saber W, Moua T, Williams EC, Verso M, Agnelli G, Couban S, Young A, De Cicco M, Biffi R, van Rooden CJ, Huisman MV, Fagnani D, Cimminiello C, Moia M, Magagnoli M, Povoski SP, Malak SF, Lee AY. Risk factors for catheter-related thrombosis (CRT) in cancer patients: a patient-level data (IPD) meta-analysis of clinical trials and prospective studies. J Thromb Haemost. 2011 Feb;9(2):312-9. doi: 10.1111/j.1538-7836.2010.04126.x.

  PMID: 21040443 BACKGROUND

• Akl EA, Kamath G, Yosuico V, Kim SY, Barba M, Sperati F, Cook DJ, Schunemann HJ. Thromboprophylaxis for patients with cancer and central venous catheters: a systematic review and a meta-analysis. Cancer. 2008 Jun;112(11):2483-92. doi: 10.1002/cncr.23479.

  PMID: 18404702 BACKGROUND

• Mollee P, Jones M, Stackelroth J, van Kuilenburg R, Joubert W, Faoagali J, Looke D, Harper J, Clements A. Catheter-associated bloodstream infection incidence and risk factors in adults with cancer: a prospective cohort study. J Hosp Infect. 2011 May;78(1):26-30. doi: 10.1016/j.jhin.2011.01.018. Epub 2011 Apr 2.

  PMID: 21459476 BACKGROUND

• Chaukiyal P, Nautiyal A, Radhakrishnan S, Singh S, Navaneethan SD. Thromboprophylaxis in cancer patients with central venous catheters. A systematic review and meta-analysis. Thromb Haemost. 2008 Jan;99(1):38-43. doi: 10.1160/TH07-07-0446.

  PMID: 18217132 BACKGROUND

• Khorana AA, Francis CW, Blumberg N, Culakova E, Refaai MA, Lyman GH. Blood transfusions, thrombosis, and mortality in hospitalized patients with cancer. Arch Intern Med. 2008 Nov 24;168(21):2377-81. doi: 10.1001/archinte.168.21.2377.

  PMID: 19029504 BACKGROUND

• Schwarz RE, Groeger JS, Coit DG. Subcutaneously implanted central venous access devices in cancer patients: a prospective analysis. Cancer. 1997 Apr 15;79(8):1635-40.

  PMID: 9118051 BACKGROUND

• Decousus H, Bourmaud A, Fournel P, Bertoletti L, Labruyere C, Presles E, Merah A, Laporte S, Stefani L, Piano FD, Jacquin JP, Meyer G, Chauvin F; ONCOCIP Investigators. Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP). Blood. 2018 Aug 16;132(7):707-716. doi: 10.1182/blood-2018-03-837153. Epub 2018 Jul 6.

  PMID: 29980524 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Pierre Fournel, MD

  Institut Cancérologique Lucien Neuwirth

  PRINCIPAL INVESTIGATOR

• Hervé DECOUSUS, MDPhD

  CIC - CHU DE SAINT-ETIENNE

  STUDY DIRECTOR

• Franck CHAUVIN, MDPhD

  Institut cancérologique Lucien Neuwirth

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 1, 2014
• Study Start: June 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 7, 2017

Record last verified: 2013-12

Locations

FR (27)