Volume substitution therapy with HES 130/0.4 (Voluven^®) versus HES 450/0.7 (hetastarch) during major orthopedic surgery

Background

The first-generation hetastarch remains the only hydroxyethyl starch (HES) available for volume substitution in the United States despite its controversial safety profile. The safety and efficacy of a new HES, Voluven^®, was assessed in this investigation.

Patients and methods

After local IRB approval and signed, written informed consent, 100 adult patients scheduled for major orthopedic surgery were randomly allocated to receive 6% HES 130/0.4 (Voluven^®, n = 49) or 6% HES 450/0.7 (hetastarch, n = 51) for intraoperative volume replacement in a double-blind fashion guided by a predefined algorithm that included CVP-guided therapy. HES volume served as the primary efficacy variable. Safety variables were: calculated total red blood cell (RBC) loss, minimum factor VIII activity and vW factor concentration between the end of surgery and 2 hours later, laboratory parameters, and adverse events through POD 28. The treatment groups were compared for equivalence in efficacy and superiority of HES 130/0.4 in safety.

Results

Demographic data and other baseline characteristics of the treatment groups were similar. Mean infused HES volumes were equivalent between groups (1615 ± 778 ml for HES 130/0.4 and 1584 ± 958 ml for HES 450/0.7). Primary safety results are presented in Table 1 (mean ± standard deviation; *P < 0.05). Three coagulopathies were reported as serious adverse events in the HES 450/0.7 group (> 3 l HES 450/0.7 administered in all cases). No coagulopathies were reported for HES 130/0.4.

Table 1 Table 1

Conclusion

HES 130/0.4 (Voluven^®) and HES 450/0.7 (hetastarch) are equally effective volume expanders in major orthopedic surgery. HES 130/0.4, however, demonstrated a more favorable safety profile including preservation of critical coagulation factors and reduced requirement for transfusion of blood products.