Dalteparin versus unfractionated heparin in critically ill patients
- PMID: 21417952
- DOI: 10.1056/NEJMoa1014475
Dalteparin versus unfractionated heparin in critically ill patients
Abstract
Background: The effects of thromboprophylaxis with low-molecular-weight heparin, as compared with unfractionated heparin, on venous thromboembolism, bleeding, and other outcomes are uncertain in critically ill patients.
Methods: In this multicenter trial, we tested the superiority of dalteparin over unfractionated heparin by randomly assigning 3764 patients to receive either subcutaneous dalteparin (at a dose of 5000 IU once daily) plus placebo once daily (for parallel-group twice-daily injections) or unfractionated heparin (at a dose of 5000 IU twice daily) while they were in the intensive care unit. The primary outcome, proximal leg deep-vein thrombosis, was diagnosed on compression ultrasonography performed within 2 days after admission, twice weekly, and as clinically indicated. Additional testing for venous thromboembolism was performed as clinically indicated. Data were analyzed according to the intention-to-treat principle.
Results: There was no significant between-group difference in the rate of proximal leg deep-vein thrombosis, which occurred in 96 of 1873 patients (5.1%) receiving dalteparin versus 109 of 1873 patients (5.8%) receiving unfractionated heparin (hazard ratio in the dalteparin group, 0.92; 95% confidence interval [CI], 0.68 to 1.23; P=0.57). The proportion of patients with pulmonary emboli was significantly lower with dalteparin (24 patients, 1.3%) than with unfractionated heparin (43 patients, 2.3%) (hazard ratio, 0.51; 95% CI, 0.30 to 0.88; P=0.01). There was no significant between-group difference in the rates of major bleeding (hazard ratio, 1.00; 95% CI, 0.75 to 1.34; P=0.98) or death in the hospital (hazard ratio, 0.92; 95% CI, 0.80 to 1.05; P=0.21). In prespecified per-protocol analyses, the results were similar to those of the main analyses, but fewer patients receiving dalteparin had heparin-induced thrombocytopenia (hazard ratio, 0.27; 95% CI, 0.08 to 0.98; P=0.046).
Conclusions: Among critically ill patients, dalteparin was not superior to unfractionated heparin in decreasing the incidence of proximal deep-vein thrombosis. (Funded by the Canadian Institutes of Health Research and others; PROTECT ClinicalTrials.gov number, NCT00182143.).
Comment in
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Dalteparin in critically ill patients.N Engl J Med. 2011 Jul 14;365(2):179-80; author reply 180. doi: 10.1056/NEJMc1105423. N Engl J Med. 2011. PMID: 21751919 No abstract available.
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Dalteparin in critically ill patients.N Engl J Med. 2011 Jul 14;365(2):179; author reply 180. doi: 10.1056/NEJMc1105423. N Engl J Med. 2011. PMID: 21751920 No abstract available.
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ACP Journal Club. Dalteparin did not differ from unfractionated heparin for reducing proximal DVT in critically ill patients.Ann Intern Med. 2011 Jul 19;155(2):JC1-7. doi: 10.7326/0003-4819-155-2-201107190-02007. Ann Intern Med. 2011. PMID: 21768573 No abstract available.
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Dalteparin and heparin-induced thrombocytopenia.N Engl J Med. 2011 Sep 22;365(12):1158; author reply 1158. doi: 10.1056/NEJMc1108392. N Engl J Med. 2011. PMID: 21992138 No abstract available.
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Does dalteparin PROTECT better than heparin?Crit Care. 2011;15(6):315. doi: 10.1186/cc10581. Epub 2011 Dec 8. Crit Care. 2011. PMID: 22152126 Free PMC article.
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