The investigators of PROTECT trial tested the superiority of dalteparin over unfractionated heparin in a multicentric trial 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.
There was no significant between-group difference in the rate of proximal leg deep-vein thrombosis, which occurred in 5.1% receiving dalteparin versus 5.8% receiving unfractionated heparin.
The proportion of patients with pulmonary emboli was significantly lower with dalteparin (24 patients, 1.3%) than with unfractionated heparin (43 patients, 2.3%).
There was no significant between-group difference in the rates of major bleeding or death in the hospital. In prespecified per-protocol analyses, the results were similar to those of the main analyses, but fewer patients receiving dalteparin had heparin-induced thrombocytopenia.
The authors concluded that among critically ill patients, dalteparin was not superior to unfractionated heparin in decreasing the incidence of proximal deep-vein thrombosis.
http://www.nejm.org/doi/full/10.1056/NEJMoa1014475?query=oncology-hematology
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