Randomized Placebo-Controlled Study of Low-Dose Warfarin for the Prevention of Central Venous Catheter–Associated Thrombosis in Patients With Cancer
In this multicenter, randomized, placebo-controlled clinical trial, we studied whether warfarin 1 mg daily reduces the incidence of symptomatic central venous catheter (CVC) -associated thrombosis in patients with cancer. Two hundred fifty-five patients with cancer who required a CVC for at least 7...
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Veröffentlicht in: | Journal of clinical oncology 2005-06, Vol.23 (18), p.4063-4069 |
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container_title | Journal of clinical oncology |
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creator | COUBAN, Stephen GOODYEAR, Michael BURNELL, Margot DOLAN, Sean WASI, Parveen BARNES, David MACLEOD, Darlene BURTON, Erica ANDREOU, Pantelis ANDERSON, David R |
description | In this multicenter, randomized, placebo-controlled clinical trial, we studied whether warfarin 1 mg daily reduces the incidence of symptomatic central venous catheter (CVC) -associated thrombosis in patients with cancer.
Two hundred fifty-five patients with cancer who required a CVC for at least 7 days were randomly assigned to receive warfarin 1 mg or placebo.
There were 11 (4.3%) symptomatic CVC-associated thromboses among 255 patients, with no difference in the incidence of symptomatic CVC-associated thrombosis between patients taking warfarin 1 mg daily (six of 130 patients; 4.6%) and patients taking placebo (five of 125 patients; 4.0%; hazard ratio, 1.20; 95% CI, 0.37 to 3.94). Warfarin had no effect on CVC life span (84 days v 63 days in control and warfarin groups, respectively; 95% confidence limit, -16 to 55 days; P = .09), and it did not affect the number of premature CVC removals (23.2% v 25.4% in control and warfarin groups, respectively; 95% confidence limit of difference -8.34 to 12.71; P = .68) or the frequency of major bleeding episodes (2% v 0% in control and warfarin groups, respectively; P = .5, Fisher's exact test).
Symptomatic CVC-associated thrombosis in patients with cancer, although significant, is less common than previously reported. In this study, the administration of warfarin 1 mg daily did not reduce the incidence of symptomatic CVC-associated thrombosis in patients with cancer. However, the low rate of symptomatic CVC-associated thrombosis means that a much larger trial is required to address this issue definitively. |
doi_str_mv | 10.1200/JCO.2005.10.192 |
format | Article |
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Two hundred fifty-five patients with cancer who required a CVC for at least 7 days were randomly assigned to receive warfarin 1 mg or placebo.
There were 11 (4.3%) symptomatic CVC-associated thromboses among 255 patients, with no difference in the incidence of symptomatic CVC-associated thrombosis between patients taking warfarin 1 mg daily (six of 130 patients; 4.6%) and patients taking placebo (five of 125 patients; 4.0%; hazard ratio, 1.20; 95% CI, 0.37 to 3.94). Warfarin had no effect on CVC life span (84 days v 63 days in control and warfarin groups, respectively; 95% confidence limit, -16 to 55 days; P = .09), and it did not affect the number of premature CVC removals (23.2% v 25.4% in control and warfarin groups, respectively; 95% confidence limit of difference -8.34 to 12.71; P = .68) or the frequency of major bleeding episodes (2% v 0% in control and warfarin groups, respectively; P = .5, Fisher's exact test).
Symptomatic CVC-associated thrombosis in patients with cancer, although significant, is less common than previously reported. In this study, the administration of warfarin 1 mg daily did not reduce the incidence of symptomatic CVC-associated thrombosis in patients with cancer. However, the low rate of symptomatic CVC-associated thrombosis means that a much larger trial is required to address this issue definitively.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.2005.10.192</identifier><identifier>PMID: 15767639</identifier><language>eng</language><publisher>Baltimore, MD: American Society of Clinical Oncology</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anticoagulants - administration & dosage ; Biological and medical sciences ; Blood and lymphatic vessels ; Cardiology. Vascular system ; Catheterization, Central Venous - adverse effects ; Catheters, Indwelling - adverse effects ; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous ; Double-Blind Method ; Female ; Humans ; Male ; Medical sciences ; Middle Aged ; Neoplasms - drug therapy ; Placebos ; Radiography ; Treatment Outcome ; Tumors ; Venous Thrombosis - diagnostic imaging ; Venous Thrombosis - etiology ; Venous Thrombosis - prevention & control ; Warfarin - administration & dosage</subject><ispartof>Journal of clinical oncology, 2005-06, Vol.23 (18), p.4063-4069</ispartof><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c403t-cf64360e19f15524788f83fd26f4b27b45129e29443f3339a89e1c2635ec637d3</citedby><cites>FETCH-LOGICAL-c403t-cf64360e19f15524788f83fd26f4b27b45129e29443f3339a89e1c2635ec637d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3716,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17020189$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15767639$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>COUBAN, Stephen</creatorcontrib><creatorcontrib>GOODYEAR, Michael</creatorcontrib><creatorcontrib>BURNELL, Margot</creatorcontrib><creatorcontrib>DOLAN, Sean</creatorcontrib><creatorcontrib>WASI, Parveen</creatorcontrib><creatorcontrib>BARNES, David</creatorcontrib><creatorcontrib>MACLEOD, Darlene</creatorcontrib><creatorcontrib>BURTON, Erica</creatorcontrib><creatorcontrib>ANDREOU, Pantelis</creatorcontrib><creatorcontrib>ANDERSON, David R</creatorcontrib><title>Randomized Placebo-Controlled Study of Low-Dose Warfarin for the Prevention of Central Venous Catheter–Associated Thrombosis in Patients With Cancer</title><title>Journal of clinical oncology</title><addtitle>J Clin Oncol</addtitle><description>In this multicenter, randomized, placebo-controlled clinical trial, we studied whether warfarin 1 mg daily reduces the incidence of symptomatic central venous catheter (CVC) -associated thrombosis in patients with cancer.
Two hundred fifty-five patients with cancer who required a CVC for at least 7 days were randomly assigned to receive warfarin 1 mg or placebo.
There were 11 (4.3%) symptomatic CVC-associated thromboses among 255 patients, with no difference in the incidence of symptomatic CVC-associated thrombosis between patients taking warfarin 1 mg daily (six of 130 patients; 4.6%) and patients taking placebo (five of 125 patients; 4.0%; hazard ratio, 1.20; 95% CI, 0.37 to 3.94). Warfarin had no effect on CVC life span (84 days v 63 days in control and warfarin groups, respectively; 95% confidence limit, -16 to 55 days; P = .09), and it did not affect the number of premature CVC removals (23.2% v 25.4% in control and warfarin groups, respectively; 95% confidence limit of difference -8.34 to 12.71; P = .68) or the frequency of major bleeding episodes (2% v 0% in control and warfarin groups, respectively; P = .5, Fisher's exact test).
Symptomatic CVC-associated thrombosis in patients with cancer, although significant, is less common than previously reported. In this study, the administration of warfarin 1 mg daily did not reduce the incidence of symptomatic CVC-associated thrombosis in patients with cancer. However, the low rate of symptomatic CVC-associated thrombosis means that a much larger trial is required to address this issue definitively.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Blood and lymphatic vessels</subject><subject>Cardiology. Vascular system</subject><subject>Catheterization, Central Venous - adverse effects</subject><subject>Catheters, Indwelling - adverse effects</subject><subject>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasms - drug therapy</subject><subject>Placebos</subject><subject>Radiography</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Venous Thrombosis - diagnostic imaging</subject><subject>Venous Thrombosis - etiology</subject><subject>Venous Thrombosis - prevention & control</subject><subject>Warfarin - administration & dosage</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkc1u1DAUhS0EokNhzQ55A6wy9U8cx8sqUH40UkdQKDvLcWziyomL7WlVVrwDEg_Ik-AwI3V1r46-c3TtA8BzjNaYIHTysTtfl8nWiyDIA7DCjPCKc8YeghXilFS4pd-OwJOUrhDCdUvZY3CEGW94Q8UK_Pmk5iFM7qcZ4NYrbfpQdWHOMXhfpM95N9zBYOEm3FZvQjLwUkWropuhDRHm0cBtNDdmzi7MC9eVNSoPv5o57BLsVEGyiX9__T5NKWinckm9GGOY-pBcgiVoq7IrrgQvXR6LY9YmPgWPrPLJPDvMY_Dl7O1F977anL_70J1uKl0jmittm5o2yGBhMWOk5m1rW2oH0ti6J7yvGSbCEFHX1FJKhWqFwZo0lBndUD7QY_Bqn3sdw4-dSVlOLmnjvZpNuV82XNRMtLiAJ3tQx5BSNFZeRzepeCcxkksVslQhlyr-C4IUx4tD9K6fzHDPH_6-AC8PgEpaeRvLy1265zgiCLcL93rPje77eOuikWlS3pdYIq90IFTiVtaoofQfRa-guA</recordid><startdate>20050620</startdate><enddate>20050620</enddate><creator>COUBAN, Stephen</creator><creator>GOODYEAR, Michael</creator><creator>BURNELL, Margot</creator><creator>DOLAN, Sean</creator><creator>WASI, Parveen</creator><creator>BARNES, David</creator><creator>MACLEOD, Darlene</creator><creator>BURTON, Erica</creator><creator>ANDREOU, Pantelis</creator><creator>ANDERSON, David R</creator><general>American Society of Clinical Oncology</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20050620</creationdate><title>Randomized Placebo-Controlled Study of Low-Dose Warfarin for the Prevention of Central Venous Catheter–Associated Thrombosis in Patients With Cancer</title><author>COUBAN, Stephen ; GOODYEAR, Michael ; BURNELL, Margot ; DOLAN, Sean ; WASI, Parveen ; BARNES, David ; MACLEOD, Darlene ; BURTON, Erica ; ANDREOU, Pantelis ; ANDERSON, David R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c403t-cf64360e19f15524788f83fd26f4b27b45129e29443f3339a89e1c2635ec637d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticoagulants - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Blood and lymphatic vessels</topic><topic>Cardiology. Vascular system</topic><topic>Catheterization, Central Venous - adverse effects</topic><topic>Catheters, Indwelling - adverse effects</topic><topic>Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasms - drug therapy</topic><topic>Placebos</topic><topic>Radiography</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Venous Thrombosis - diagnostic imaging</topic><topic>Venous Thrombosis - etiology</topic><topic>Venous Thrombosis - prevention & control</topic><topic>Warfarin - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>COUBAN, Stephen</creatorcontrib><creatorcontrib>GOODYEAR, Michael</creatorcontrib><creatorcontrib>BURNELL, Margot</creatorcontrib><creatorcontrib>DOLAN, Sean</creatorcontrib><creatorcontrib>WASI, Parveen</creatorcontrib><creatorcontrib>BARNES, David</creatorcontrib><creatorcontrib>MACLEOD, Darlene</creatorcontrib><creatorcontrib>BURTON, Erica</creatorcontrib><creatorcontrib>ANDREOU, Pantelis</creatorcontrib><creatorcontrib>ANDERSON, David R</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>COUBAN, Stephen</au><au>GOODYEAR, Michael</au><au>BURNELL, Margot</au><au>DOLAN, Sean</au><au>WASI, Parveen</au><au>BARNES, David</au><au>MACLEOD, Darlene</au><au>BURTON, Erica</au><au>ANDREOU, Pantelis</au><au>ANDERSON, David R</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized Placebo-Controlled Study of Low-Dose Warfarin for the Prevention of Central Venous Catheter–Associated Thrombosis in Patients With Cancer</atitle><jtitle>Journal of clinical oncology</jtitle><addtitle>J Clin Oncol</addtitle><date>2005-06-20</date><risdate>2005</risdate><volume>23</volume><issue>18</issue><spage>4063</spage><epage>4069</epage><pages>4063-4069</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>In this multicenter, randomized, placebo-controlled clinical trial, we studied whether warfarin 1 mg daily reduces the incidence of symptomatic central venous catheter (CVC) -associated thrombosis in patients with cancer.
Two hundred fifty-five patients with cancer who required a CVC for at least 7 days were randomly assigned to receive warfarin 1 mg or placebo.
There were 11 (4.3%) symptomatic CVC-associated thromboses among 255 patients, with no difference in the incidence of symptomatic CVC-associated thrombosis between patients taking warfarin 1 mg daily (six of 130 patients; 4.6%) and patients taking placebo (five of 125 patients; 4.0%; hazard ratio, 1.20; 95% CI, 0.37 to 3.94). Warfarin had no effect on CVC life span (84 days v 63 days in control and warfarin groups, respectively; 95% confidence limit, -16 to 55 days; P = .09), and it did not affect the number of premature CVC removals (23.2% v 25.4% in control and warfarin groups, respectively; 95% confidence limit of difference -8.34 to 12.71; P = .68) or the frequency of major bleeding episodes (2% v 0% in control and warfarin groups, respectively; P = .5, Fisher's exact test).
Symptomatic CVC-associated thrombosis in patients with cancer, although significant, is less common than previously reported. In this study, the administration of warfarin 1 mg daily did not reduce the incidence of symptomatic CVC-associated thrombosis in patients with cancer. However, the low rate of symptomatic CVC-associated thrombosis means that a much larger trial is required to address this issue definitively.</abstract><cop>Baltimore, MD</cop><pub>American Society of Clinical Oncology</pub><pmid>15767639</pmid><doi>10.1200/JCO.2005.10.192</doi><tpages>7</tpages></addata></record> |
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source | MEDLINE; American Society of Clinical Oncology Online Journals; EZB-FREE-00999 freely available EZB journals |
subjects | Adolescent Adult Aged Aged, 80 and over Anticoagulants - administration & dosage Biological and medical sciences Blood and lymphatic vessels Cardiology. Vascular system Catheterization, Central Venous - adverse effects Catheters, Indwelling - adverse effects Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous Double-Blind Method Female Humans Male Medical sciences Middle Aged Neoplasms - drug therapy Placebos Radiography Treatment Outcome Tumors Venous Thrombosis - diagnostic imaging Venous Thrombosis - etiology Venous Thrombosis - prevention & control Warfarin - administration & dosage |
title | Randomized Placebo-Controlled Study of Low-Dose Warfarin for the Prevention of Central Venous Catheter–Associated Thrombosis in Patients With Cancer |
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