Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial
There is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by cond...
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| Veröffentlicht in: | PloS one 2018-06, Vol.13 (6), p.e0198285-e0198285 |
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| creator | Pai, Menaka Adhikari, Neill K J Ostermann, Marlies Heels-Ansdell, Diane Douketis, James D Skrobik, Yoanna Qushmaq, Ismael Meade, Maureen Guyatt, Gordon Geerts, William Walsh, Michael W Crowther, Mark A Friedrich, Jan O Burry, Lisa Bellomo, Rinaldo Brandão da Silva, Nilton Costa Filho, Rubens Cox, Michael J Alves Silva, Suzana Cook, Deborah J |
| description | There is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by conducting a subgroup analysis of PROTECT, a randomized blinded trial.
We studied intensive care unit (ICU) patients with pre-ICU dialysis-dependent end-stage renal disease (ESRD; pre-specified subgroup; n = 118), or severe renal dysfunction at ICU admission (defined as ESRD or non-dialysis dependent with creatinine clearance [CrCl] |
| doi_str_mv | 10.1371/journal.pone.0198285 |
| format | Article |
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We studied intensive care unit (ICU) patients with pre-ICU dialysis-dependent end-stage renal disease (ESRD; pre-specified subgroup; n = 118), or severe renal dysfunction at ICU admission (defined as ESRD or non-dialysis dependent with creatinine clearance [CrCl] <30 ml/min; post hoc subgroup; n = 590). We compared dalteparin, 5000 IU daily, with unfractionated heparin (UFH), 5000 IU twice daily, and considered outcomes of proximal leg deep vein thrombosis (DVT); pulmonary embolism (PE); any VTE; and major bleeding. Adjusted hazard ratios [HR] were calculated using Cox regression.
In patients with ESRD, there was no significant difference in DVT (8.3% vs. 5.2%, p = 0.76), any VTE (10.0% vs. 6.9%; p = 0.39) or major bleeding (5.0% vs. 8.6%; p = 0.32) between UFH and dalteparin. In patients with severe renal dysfunction, there was no significant difference in any VTE (10.0% vs. 6.4%; p = 0.07) or major bleeding (8.9% vs. 11.0%; p = 0.66) but an increase in DVT with dalteparin (7.6% vs. 3.7%; p = 0.04). Interaction p-values for comparisons of HRs (ESRD versus not) were non-significant.
In critically ill patients with ESRD, or severe renal dysfunction, there was no significant difference in any VTE or major bleeding between UFH and dalteparin. Patients with severe renal dysfunction who received dalteparin had more proximal DVTs than those on UFH; this finding did not hold in patients with ESRD alone.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0198285</identifier><identifier>PMID: 29856817</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anticoagulants ; Anticoagulants - therapeutic use ; Bioaccumulation ; Bleeding ; Care and treatment ; Chemoprevention - methods ; Creatinine ; Critical care ; Critical Care - methods ; Critical Illness - therapy ; Dialysis ; Dosage and administration ; Drug dosages ; Drug therapy ; Embolism ; Embolisms ; End-stage renal disease ; Female ; Glycoproteins ; Health aspects ; Heparin ; Heparin, Low-Molecular-Weight - therapeutic use ; Hospitals ; Humans ; Intensive care ; Internal medicine ; Kidney diseases ; Kidney failure ; Kidney Failure, Chronic - drug therapy ; Laboratories ; Male ; Medical research ; Medicine ; Medicine and Health Sciences ; Methods ; Middle Aged ; Molecular chains ; Patients ; Peritoneal dialysis ; Prophylaxis ; Regression analysis ; Renal function ; Research and Analysis Methods ; Research methodology ; Sick persons ; Studies ; Subgroups ; Thromboembolism ; Thrombosis ; Venous Thromboembolism - prevention & control ; Venous thrombosis</subject><ispartof>PloS one, 2018-06, Vol.13 (6), p.e0198285-e0198285</ispartof><rights>COPYRIGHT 2018 Public Library of Science</rights><rights>2018 Pai et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2018 Pai et al 2018 Pai et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-6066a311154fa2f6fdb0dac3cc7f090331b160e2f60cbc5b6409d11d924333c83</citedby><cites>FETCH-LOGICAL-c692t-6066a311154fa2f6fdb0dac3cc7f090331b160e2f60cbc5b6409d11d924333c83</cites><orcidid>0000-0002-6053-689X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5983525/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5983525/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,861,882,2096,2915,23847,27905,27906,53772,53774,79349,79350</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29856817$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>ten Cate, Hugo</contributor><creatorcontrib>Pai, Menaka</creatorcontrib><creatorcontrib>Adhikari, Neill K J</creatorcontrib><creatorcontrib>Ostermann, Marlies</creatorcontrib><creatorcontrib>Heels-Ansdell, Diane</creatorcontrib><creatorcontrib>Douketis, James D</creatorcontrib><creatorcontrib>Skrobik, Yoanna</creatorcontrib><creatorcontrib>Qushmaq, Ismael</creatorcontrib><creatorcontrib>Meade, Maureen</creatorcontrib><creatorcontrib>Guyatt, Gordon</creatorcontrib><creatorcontrib>Geerts, William</creatorcontrib><creatorcontrib>Walsh, Michael W</creatorcontrib><creatorcontrib>Crowther, Mark A</creatorcontrib><creatorcontrib>Friedrich, Jan O</creatorcontrib><creatorcontrib>Burry, Lisa</creatorcontrib><creatorcontrib>Bellomo, Rinaldo</creatorcontrib><creatorcontrib>Brandão da Silva, Nilton</creatorcontrib><creatorcontrib>Costa Filho, Rubens</creatorcontrib><creatorcontrib>Cox, Michael J</creatorcontrib><creatorcontrib>Alves Silva, Suzana</creatorcontrib><creatorcontrib>Cook, Deborah J</creatorcontrib><creatorcontrib>PROTECT (Prophylaxis for Thromboembolism in Critical Care Trial) Investigators</creatorcontrib><creatorcontrib>on behalf of the PROTECT (Prophylaxis for Thromboembolism in Critical Care Trial) Investigators</creatorcontrib><title>Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>There is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by conducting a subgroup analysis of PROTECT, a randomized blinded trial.
We studied intensive care unit (ICU) patients with pre-ICU dialysis-dependent end-stage renal disease (ESRD; pre-specified subgroup; n = 118), or severe renal dysfunction at ICU admission (defined as ESRD or non-dialysis dependent with creatinine clearance [CrCl] <30 ml/min; post hoc subgroup; n = 590). We compared dalteparin, 5000 IU daily, with unfractionated heparin (UFH), 5000 IU twice daily, and considered outcomes of proximal leg deep vein thrombosis (DVT); pulmonary embolism (PE); any VTE; and major bleeding. Adjusted hazard ratios [HR] were calculated using Cox regression.
In patients with ESRD, there was no significant difference in DVT (8.3% vs. 5.2%, p = 0.76), any VTE (10.0% vs. 6.9%; p = 0.39) or major bleeding (5.0% vs. 8.6%; p = 0.32) between UFH and dalteparin. In patients with severe renal dysfunction, there was no significant difference in any VTE (10.0% vs. 6.4%; p = 0.07) or major bleeding (8.9% vs. 11.0%; p = 0.66) but an increase in DVT with dalteparin (7.6% vs. 3.7%; p = 0.04). Interaction p-values for comparisons of HRs (ESRD versus not) were non-significant.
In critically ill patients with ESRD, or severe renal dysfunction, there was no significant difference in any VTE or major bleeding between UFH and dalteparin. Patients with severe renal dysfunction who received dalteparin had more proximal DVTs than those on UFH; this finding did not hold in patients with ESRD alone.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anticoagulants</subject><subject>Anticoagulants - therapeutic use</subject><subject>Bioaccumulation</subject><subject>Bleeding</subject><subject>Care and treatment</subject><subject>Chemoprevention - methods</subject><subject>Creatinine</subject><subject>Critical care</subject><subject>Critical Care - methods</subject><subject>Critical Illness - therapy</subject><subject>Dialysis</subject><subject>Dosage and administration</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Embolism</subject><subject>Embolisms</subject><subject>End-stage renal disease</subject><subject>Female</subject><subject>Glycoproteins</subject><subject>Health aspects</subject><subject>Heparin</subject><subject>Heparin, Low-Molecular-Weight - therapeutic use</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Intensive care</subject><subject>Internal medicine</subject><subject>Kidney diseases</subject><subject>Kidney failure</subject><subject>Kidney Failure, Chronic - drug therapy</subject><subject>Laboratories</subject><subject>Male</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Methods</subject><subject>Middle Aged</subject><subject>Molecular chains</subject><subject>Patients</subject><subject>Peritoneal dialysis</subject><subject>Prophylaxis</subject><subject>Regression analysis</subject><subject>Renal function</subject><subject>Research and Analysis Methods</subject><subject>Research methodology</subject><subject>Sick persons</subject><subject>Studies</subject><subject>Subgroups</subject><subject>Thromboembolism</subject><subject>Thrombosis</subject><subject>Venous Thromboembolism - prevention & 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heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial</title><author>Pai, Menaka ; Adhikari, Neill K J ; Ostermann, Marlies ; Heels-Ansdell, Diane ; Douketis, James D ; Skrobik, Yoanna ; Qushmaq, Ismael ; Meade, Maureen ; Guyatt, Gordon ; Geerts, William ; Walsh, Michael W ; Crowther, Mark A ; Friedrich, Jan O ; Burry, Lisa ; Bellomo, Rinaldo ; Brandão da Silva, Nilton ; Costa Filho, Rubens ; Cox, Michael J ; Alves Silva, Suzana ; Cook, Deborah J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-6066a311154fa2f6fdb0dac3cc7f090331b160e2f60cbc5b6409d11d924333c83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anticoagulants</topic><topic>Anticoagulants - therapeutic use</topic><topic>Bioaccumulation</topic><topic>Bleeding</topic><topic>Care and treatment</topic><topic>Chemoprevention - methods</topic><topic>Creatinine</topic><topic>Critical care</topic><topic>Critical Care - methods</topic><topic>Critical Illness - therapy</topic><topic>Dialysis</topic><topic>Dosage and administration</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Embolism</topic><topic>Embolisms</topic><topic>End-stage renal disease</topic><topic>Female</topic><topic>Glycoproteins</topic><topic>Health aspects</topic><topic>Heparin</topic><topic>Heparin, Low-Molecular-Weight - therapeutic use</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Intensive care</topic><topic>Internal medicine</topic><topic>Kidney diseases</topic><topic>Kidney failure</topic><topic>Kidney Failure, Chronic - drug therapy</topic><topic>Laboratories</topic><topic>Male</topic><topic>Medical research</topic><topic>Medicine</topic><topic>Medicine and Health 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Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni 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Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pai, Menaka</au><au>Adhikari, Neill K J</au><au>Ostermann, Marlies</au><au>Heels-Ansdell, Diane</au><au>Douketis, James D</au><au>Skrobik, Yoanna</au><au>Qushmaq, Ismael</au><au>Meade, Maureen</au><au>Guyatt, Gordon</au><au>Geerts, William</au><au>Walsh, Michael W</au><au>Crowther, Mark A</au><au>Friedrich, Jan O</au><au>Burry, Lisa</au><au>Bellomo, Rinaldo</au><au>Brandão da Silva, Nilton</au><au>Costa Filho, Rubens</au><au>Cox, Michael J</au><au>Alves Silva, Suzana</au><au>Cook, Deborah J</au><au>ten Cate, Hugo</au><aucorp>PROTECT (Prophylaxis for Thromboembolism in Critical Care Trial) Investigators</aucorp><aucorp>on behalf of the PROTECT (Prophylaxis for Thromboembolism in Critical Care Trial) Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2018-06-01</date><risdate>2018</risdate><volume>13</volume><issue>6</issue><spage>e0198285</spage><epage>e0198285</epage><pages>e0198285-e0198285</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>There is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by conducting a subgroup analysis of PROTECT, a randomized blinded trial.
We studied intensive care unit (ICU) patients with pre-ICU dialysis-dependent end-stage renal disease (ESRD; pre-specified subgroup; n = 118), or severe renal dysfunction at ICU admission (defined as ESRD or non-dialysis dependent with creatinine clearance [CrCl] <30 ml/min; post hoc subgroup; n = 590). We compared dalteparin, 5000 IU daily, with unfractionated heparin (UFH), 5000 IU twice daily, and considered outcomes of proximal leg deep vein thrombosis (DVT); pulmonary embolism (PE); any VTE; and major bleeding. Adjusted hazard ratios [HR] were calculated using Cox regression.
In patients with ESRD, there was no significant difference in DVT (8.3% vs. 5.2%, p = 0.76), any VTE (10.0% vs. 6.9%; p = 0.39) or major bleeding (5.0% vs. 8.6%; p = 0.32) between UFH and dalteparin. In patients with severe renal dysfunction, there was no significant difference in any VTE (10.0% vs. 6.4%; p = 0.07) or major bleeding (8.9% vs. 11.0%; p = 0.66) but an increase in DVT with dalteparin (7.6% vs. 3.7%; p = 0.04). Interaction p-values for comparisons of HRs (ESRD versus not) were non-significant.
In critically ill patients with ESRD, or severe renal dysfunction, there was no significant difference in any VTE or major bleeding between UFH and dalteparin. Patients with severe renal dysfunction who received dalteparin had more proximal DVTs than those on UFH; this finding did not hold in patients with ESRD alone.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>29856817</pmid><doi>10.1371/journal.pone.0198285</doi><tpages>e0198285</tpages><orcidid>https://orcid.org/0000-0002-6053-689X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2018-06, Vol.13 (6), p.e0198285-e0198285 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2049517841 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adult Aged Aged, 80 and over Anticoagulants Anticoagulants - therapeutic use Bioaccumulation Bleeding Care and treatment Chemoprevention - methods Creatinine Critical care Critical Care - methods Critical Illness - therapy Dialysis Dosage and administration Drug dosages Drug therapy Embolism Embolisms End-stage renal disease Female Glycoproteins Health aspects Heparin Heparin, Low-Molecular-Weight - therapeutic use Hospitals Humans Intensive care Internal medicine Kidney diseases Kidney failure Kidney Failure, Chronic - drug therapy Laboratories Male Medical research Medicine Medicine and Health Sciences Methods Middle Aged Molecular chains Patients Peritoneal dialysis Prophylaxis Regression analysis Renal function Research and Analysis Methods Research methodology Sick persons Studies Subgroups Thromboembolism Thrombosis Venous Thromboembolism - prevention & control Venous thrombosis |
| title | Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial |
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