Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction : A subgroup analysis of the PROTECT trial
INTRODUCTION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2018 |
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| Erschienen: |
2018 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
PloS one - 13(2018), 6 vom: 01., Seite e0198285 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pai, Menaka [VerfasserIn] |
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| Links: |
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| Themen: |
Anticoagulants |
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| Anmerkungen: |
Date Completed 11.01.2019 Date Revised 11.01.2019 published: Electronic-eCollection Citation Status MEDLINE |
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| doi: |
10.1371/journal.pone.0198285 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM285020307 |
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| 100 | 1 | |a Pai, Menaka |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction |b A subgroup analysis of the PROTECT trial |
| 264 | 1 | |c 2018 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 11.01.2019 | ||
| 500 | |a Date Revised 11.01.2019 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a INTRODUCTION: 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 | ||
| 520 | |a METHODS: 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 | ||
| 520 | |a RESULTS: 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 | ||
| 520 | |a CONCLUSIONS: 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
| 650 | 7 | |a Heparin, Low-Molecular-Weight |2 NLM | |
| 700 | 1 | |a Adhikari, Neill K J |e verfasserin |4 aut | |
| 700 | 1 | |a Ostermann, Marlies |e verfasserin |4 aut | |
| 700 | 1 | |a Heels-Ansdell, Diane |e verfasserin |4 aut | |
| 700 | 1 | |a Douketis, James D |e verfasserin |4 aut | |
| 700 | 1 | |a Skrobik, Yoanna |e verfasserin |4 aut | |
| 700 | 1 | |a Qushmaq, Ismael |e verfasserin |4 aut | |
| 700 | 1 | |a Meade, Maureen |e verfasserin |4 aut | |
| 700 | 1 | |a Guyatt, Gordon |e verfasserin |4 aut | |
| 700 | 1 | |a Geerts, William |e verfasserin |4 aut | |
| 700 | 1 | |a Walsh, Michael W |e verfasserin |4 aut | |
| 700 | 1 | |a Crowther, Mark A |e verfasserin |4 aut | |
| 700 | 1 | |a Friedrich, Jan O |e verfasserin |4 aut | |
| 700 | 1 | |a Burry, Lisa |e verfasserin |4 aut | |
| 700 | 1 | |a Bellomo, Rinaldo |e verfasserin |4 aut | |
| 700 | 1 | |a Brandão da Silva, Nilton |e verfasserin |4 aut | |
| 700 | 1 | |a Costa Filho, Rubens |e verfasserin |4 aut | |
| 700 | 1 | |a Cox, Michael J |e verfasserin |4 aut | |
| 700 | 1 | |a Alves Silva, Suzana |e verfasserin |4 aut | |
| 700 | 1 | |a Cook, Deborah J |e verfasserin |4 aut | |
| 700 | 0 | |a PROTECT (Prophylaxis for Thromboembolism in Critical Care Trial) Investigators |e verfasserin |4 aut | |
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