Background: Perioperative blood salvage is commonly used in cardiovascular surgery and has been more recently introduced in major orthopedic surgery. Limited information is available on the influence of re-infused whole blood on the hemostatic system in orthopedic patients. Materials and methods: The aim of this study was to assess whether perioperative salvage and re-infusion of unwashed whole blood is associated with an activation of blood coagulation in patients undergoing total knee replacement. Consecutive patients receiving re-infusion were included in the study (n=13). Patients undergoing total knee replacement without perioperative blood salvage and re-infusion served as controls (n=6). In patients receiving re-infusion thrombin-antithrombin complexes (TAT), plasmin-antiplasmin complexes (PAP) and fibrinogen were assayed at the following times: before surgery (baseline), immediately before re-infusion (TO), immediately (T1), 2 h (T2) and 24 h (T3) after the end of re-infusion. In control patients blood samples were drawn at the average times corresponding to each of the sampling time in the patients receiving re-infusion. The first post-surgery LMWH dose was given within 12 h after surgery. Results: TAT and PAP increased after surgery both in patients receiving re-infusion and controls. An increase of TAT and PAP was observed immediately after re-infusion with respect to baseline (TAT 513.1 +/- 259.1 mug/l vs. 5.3 +/- 4.9, p<0.0001; PAP 7408.0 +/- 1892.1 mug/l vs. 461.4 +/- 217.1, p<0.0001) and to controls (TAT 60.4 +/- 26.9 mug/l, p=0.002; PAP 2208.3 +/- 1446.4 mug/l, p<0.001). The levels of TAT and PAP in patients receiving re-infusion remained high at 2 h after re-infusion compared to those of the controls (TAT 124.1 +/- 38.3 mug/l vs. 38.08 +/- 18.9, p=0.016; PAP 5690.7 +/- 1435.5 mug/l vs. 1613.9 +/- 706.0, p<0.001) and decreased 24 h thereafter. Fibrinogen level was tower in patients receiving re-infusion compared to controls. Conclusions: Whole blood reinfusion is associated with an activation of blood coagulation in patients undergoing total knee replacement. The clinical relevance of this activation has to be tested in prospective studies with adequate sample size. (C) 2004 Elsevier Ltd. All rights reserved.