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

Cancer Clinical Trial

— ONCOCIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025894
• Other study ID #: 2010-01
• Secondary ID: 2010-A01064-35
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: March 6, 2017
• Start date: June 2010
• Est. completion date: March 2015

Study information

• Verified date: December 2013
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3032
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
France	CH d'Annecy	Annecy
France	CH Intercommunal Annemasse-Bonneville	Annemasse
France	Polyclinique de Savoie	Annemasse
France	CH Chambéry	Chambéry
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Pôle Santé république	Clermont-Ferrand
France	CH Feurs	Feurs
France	Institut Daniel Hollard	Grenoble
France	CH EmileRoux	Le Puy en Velay
France	CH Lyon Sud	Lyon
France	Clinique de la sauvergarde	Lyon
France	Clinique Eugène André	Lyon
France	Clinique Portes du Sud	Lyon
France	Clinique Saint-Joseph Saint-Luc	Lyon
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Desgenettes	Lyon
France	Hôpital privé Jean-Mermoz	Lyon
France	Infirmerie Protestante	Lyon
France	CH de Montbrison	Montbrison
France	CH de Roanne	Roanne
France	Institut Cancérologique Lucien neuwirth	Saint Priest en Jarez
France	CH Pays du Gier	Saint-Chamond
France	CHU Saint-Etienne Service de Gastroentérologie	Saint-Etienne
France	CHU Saint-Etienne Service de Gynécologie	Saint-Etienne
France	Hôpital privé de la Loire	Saint-Etienne
France	Hôpitaux du Léman	Thonon-les-bains
France	Hôpital Privé Drôme Ardèche	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

References & Publications (8)

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. — View Citation

Akl EA, Kamath G, Yosuico V, Kim SY, Barba M, Sperati F, Cook DJ, Schünemann 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. Review. — View Citation

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. Review. — View Citation

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, Büller 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolic complications:		one year
Primary	Locoregional or disseminated infectious complications:		one year
Secondary	Medical and economic consequences of these complications		one year