The effect of 6% hydroxyethyl starch 130/0.4 on hemodynamic efficacy and hemostasis in major orthopedic surgery: a comparison with 6% hydroxyethyl starch 200/0.5

Background Clinical trial on patients undergoing major orthopedic surgeries to assess the safety and efficacy of 6% hydroxyethyl starch (HES) 130/0.4 (voluven) in comparison with 6% HES (200/0.5). Patients and methods A total of 40 patients scheduled for major orthopedic surgery were randomized to receive either 6% HES 130/0.4 (voluven group) or 6% HES 200/0.5 (haesteril group) during the intraoperative period. Amount of given colloids and crystalloids, blood loss, and the number of patients who needed blood transfusion were recorded. Mean blood pressure and heart rate were recorded at four time points during the operation. Laboratory measurements included hemoglobin, platelet count, prothrombin time, activated partial thromboplastin time, fibrinogen, and factor VIII concentrations. They were recorded before the surgery (baseline) and at 6 and 24 h after the surgery. Results Mean blood pressure and heart rate were comparable between both groups. There was equivalence of mean infused volumes of voluven and haesteril during the study period (P = 0.086). The intraoperative blood loss was significantly lower in the voluven group than in the haesteril group (P = 0.001), and a smaller number of patients in the voluven group required blood transfusion compared with the haesteril group (P = 0.023). Hemoglobin and platelets decreased significantly at 6 and 24 h after surgery compared with the baseline values, with insignificant difference between both groups. Prothrombin time increased significantly at 6 and 24 h after surgery in both the groups. The increase was significantly more in the haesteril group. Activated partial thromboplastin time increased significantly in the haesteril group at 6 and 24 h after surgery, whereas there was a nonsignificant change in the voluven group. Factor VIII concentration showed a significantly larger increase at 6 and 24 h after surgery in the voluven group than in the haesteril group. Conclusion In surgeries with major blood loss, voluven has a comparable efficacy to haesteril and may reduce coagulation impairment, possibly leading to less requirements of allogenic blood transfusion.