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[Assessment of complications of major orthopedic surgery: comparison of indobufen, calcium heparin, and low molecular heparin].

OBJECTIVE
Evaluation of incidence of postoperative thrombotic and haemorrhagic complications in autotrasfused patients undergoing blood predepositing, hemodilution, intra and postoperative blood saving and treated with indobufen, heparin calcine and low molecular weight heparin (enoxeparin).


EXPERIMENTAL DESIGN
Comparative study. Length of follow up: 6 months.


SETTING
Three division of Orthopaedic Surgery related to 1st Anaesthesiology and Intensive Care Unit of Rizzoli Orthopaedic Institute.


PATIENTS
980 consecutive patients admitted to hospital from 1-1-1992 to 30-6-1994 (321 males and 159 females), aged between 20 and 90 years (mean 62 +/- 11 years), with basal hemoglobin at 13.4 +/- 1.4 g/dI (range 6.7-17.9), who had undergone antithromboembolic prophylaxis with indobufen (Indo, 668), heparin calcine (CaHe, 200) and low molecular weight heparin (LMWH).


INTERVENTIONS
Total hip (714) and knee (121) arthroprosthesis and hip replacements (cup 33, stem 10, cup and stem 102).


MEASUREMENTS
The incidence of death, thromboembolic complications (pulmonary embolism, deep vein thrombosis), hemorrhage (hematoma and homologous transfusions), cardiac ischaemia. ANOVA and contingency tables (CT) were used for statistical.


RESULTS
The absence of complications was significantly greater in patients treated with indobufen (Indo 94.3% vs CaHe 83.5% vs LMWH 85.7%, CT: p = 0.0001); the incidence of thromboembolic complications was significantly higher in patients treated with heparin calcine and low molecular weight heparin; in patients treated with heparin calcine the incidence of haemorrhagic complications was significantly higher. Due to bleeding brought about by the use of heparin calcine, one patient with coronary heart disease suffered from anemia and severe hypotensions by myocardiac infarction and cardiogenous shock which led to the patient's death. The use of homologous transfusions was significantly higher in patients treated with heparin calcine (Indo 4.2% vs CaHe 14.5% vs LMWH 4.5%, CT: p = 0.0001).


CONCLUSIONS
In patients undergoing autotransfusion and hemodilution, indobufen has a lower of haemorrhagic complications compared to heparine calcine and low molecular weight heparin and it is more effective in the prevention of thrombotic complications at clinical evidence.