• Mitchell Levy, Marcel Levi, Mark D Williams, Massimo Antonelli, Dazhe Wang, and Mariano Alejandro Mignini.
• Rhode Island Hospital and Brown University Medical School, 593 Eddy St., Providence, RI 02903, USA. mitchell_levy@brown.edu
• Intensive Care Med. 2009 Jul 1;35(7):1196-203.

PurposeThe safety of using heparin concomitantly with drotrecogin alfa (activated) {DrotAA} was explored in the XPRESS study. No heparin effect on mortality was observed. Safety results from that study are explored in more detail.MethodsA randomized, double-blind trial of prophylactic heparin versus placebo in severe sepsis patients treated with DrotAA (24 microg/(kg h) for 96 h) was conducted at 224 sites in 20 countries. Patients were randomized 1:1:2 to receive unfractionated heparin (UFH) (5,000 Units twice daily) (n = 511), low-molecular-weight heparin (LMWH) (enoxaparin, 40 mg per day) (n = 493), or placebo (n = 990) every 12 h during the DrotAA infusion.ResultsBleeding events during the DrotAA infusion period (Days 0-6) were higher in the heparin than placebo groups (10.8 vs. 8.1%; p = 0.049), but serious bleeding events were similar (heparin 2.3% vs. placebo 2.5%; p = 0.72) and central nervous system (CNS) bleeds were rare in both groups (0.3 vs. 0.3%). Fewer heparin patients experienced an ischemic stroke during infusion (0.3 vs. 1.3%; p = 0.018) and 28-day period (0.5 vs. 1.8%; p = 0.009).ConclusionsCoadministration of DrotAA with low-dose heparin in severe sepsis patients did not increase incidence of serious bleeding. Fewer ischemic strokes in the heparin group suggest heparin cessation should be avoided during DrotAA infusion.

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