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.
| RBC loss (l) | Factor VIII (%) with >1 l HES | vW factor (%) with >1 l HES | RBC use (ml/kg) | |
|---|---|---|---|---|
| HES 130/0.4 | 1.17 ± 0.63 | 88.7 ± 55.7 | 89.2 ± 40.4 | 8.0 ± 6.4 |
| HES 450/0.7 | 1.31 ± 0.84 | 65.9 ± 39.4* | 71.5 ± 36.9* | 13.8 ± 12.9* |
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.