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PROTECT: Dalteparin not superior to unfractionated heparin in critically ill patients
Cook D. N Engl J Med. 2011;doi:10.1056/NEJMoa1014475.
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The incidence of proximal deep vein thrombosis for critically ill patients given dalteparin was not superior to the rate found among patients treated with unfractionated heparin, study findings indicated.
Investigators of the multicenter, international Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT) randomly assigned patients who were in the ICU to receive either 5,000 IU once daily of subcutaneous dalteparin (Fragmin, Eisai; n=1,862) plus placebo or 5,000 IU twice daily of unfractionated heparin (n=1,862). Proximal deep vein thrombosis, the study’s primary endpoint, was diagnosed with compression ultrasonography within 2 days after admission, and then twice weekly.
According to results, there was no significant difference in the primary endpoint between groups (dalteparin, 5.1% vs. unfractionated heparin, 5.8%), nor was there in rates of major bleeding (P=.98) or in-hospital death (P=.21). However, researchers found that a significantly lower percentage of patients had pulmonary emboli in the dalteparin group (1.3% vs. 2.3%; HR=0.51; 95% CI, 0.3-0.88). Results of additional analyses, including adjusted, as-treated and sensitivity, were similar to the main, unadjusted analysis.
In the study’s discussion, the researchers said the results may have been different if the study enrollment had been larger or if they had used different drugs or doses. Regarding the potential effect of study size, they said, “It is possible that in a larger trial, [differences in proximal deep vein thrombosis] might have been detected.”
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