Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study
NCT ID: NCT02025894
Last Updated: 2017-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3032 participants
OBSERVATIONAL
2010-06-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PCVCs
Cohort of cancer patients with indication PCVC under the usual practice
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Therapeutic doses of anticoagulants required at inclusion,
* PCVC inserted by the femoral vein
18 Years
ALL
No
Sponsors
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Institut de Cancérologie de la Loire
OTHER
Responsible Party
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Principal Investigators
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Pierre Fournel, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Cancérologique Lucien Neuwirth
Hervé DECOUSUS, MDPhD
Role: STUDY_DIRECTOR
CIC - CHU DE SAINT-ETIENNE
Franck CHAUVIN, MDPhD
Role: STUDY_DIRECTOR
Institut cancérologique Lucien Neuwirth
Locations
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CH d'Annecy
Annecy, France, France
CH Intercommunal Annemasse-Bonneville
Annemasse, France, France
Polyclinique de Savoie
Annemasse, France, France
CH Chambéry
Chambéry, France, France
CHU Clermont-Ferrand
Clermont-Ferrand, France, France
Pôle Santé république
Clermont-Ferrand, France, France
CH Feurs
Feurs, France, France
Institut Daniel Hollard
Grenoble, France, France
CH EmileRoux
Le Puy-en-Velay, France, France
CH Lyon Sud
Lyon, France, France
Clinique de la sauvergarde
Lyon, France, France
Clinique Eugène André
Lyon, France, France
Clinique Portes du Sud
Lyon, France, France
Clinique Saint-Joseph Saint-Luc
Lyon, France, France
Hôpital de la Croix Rousse
Lyon, France, France
Hôpital Desgenettes
Lyon, France, France
Hôpital privé Jean-Mermoz
Lyon, France, France
Infirmerie Protestante
Lyon, France, France
CH de Montbrison
Montbrison, France, France
CH de Roanne
Roanne, France, France
CH Pays du Gier
Saint-Chamond, France, France
CHU Saint-Etienne Service de Gynécologie
Saint-Etienne, France, France
CHU Saint-Etienne Service de Gastroentérologie
Saint-Etienne, France, France
Hôpital privé de la Loire
Saint-Etienne, France, France
Institut Cancérologique Lucien neuwirth
Saint-Priest-en-Jarez, France, France
Hôpitaux du Léman
Thonon-les-Bains, France, France
Hôpital Privé Drôme Ardèche
Valence, France, France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2010-A01064-35
Identifier Type: OTHER
Identifier Source: secondary_id
2010-01
Identifier Type: -
Identifier Source: org_study_id
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