- Poster presentation
- Open Access
Volume substitution therapy with HES 130/0.4 (Voluven®) versus HES 450/0.7 (hetastarch) during major orthopedic surgery
Critical Care volume 9, Article number: P206 (2005)
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.
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.
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.
About this article
Cite this article
Gandhi, S., Warltier, D., Weiskopf, R. et al. Volume substitution therapy with HES 130/0.4 (Voluven®) versus HES 450/0.7 (hetastarch) during major orthopedic surgery. Crit Care 9, P206 (2005). https://doi.org/10.1186/cc3269
- Factor Viii
- Hydroxyethyl Starch
- Favorable Safety Profile
- Factor Viii Activity