Advantages of 6% hydroxyethyl starch 130/0.4 (Voluven^®) at repetitive high dose levels in patients with severe cranio-cerebral trauma

Introduction

Regarding the use of high dose hydroxyethyl starch (HES) in patients with cranio-cerebral trauma (CCT), potential side effects on blood coagulation are primarily due to the decrease in Factor VIII activity (F VIII:C) and von Willebrand factor (vWF:Ag). These effects are correlated with average molecular weight and molar substitution of the specific HES, which were optimized in a new HES solution, HES 130/0.4 (6%, Voluven^®).

Patients and methods

Thirty-one patients with severe CCT were randomized after ICU admission to receive one of two different 6% HES solutions for up to 28 days. Group A: HES 130/0.4 (Voluven^®) up to 70 ml/kg BW/day (n = 16). Group B: HES 200/0.5 (HAES-steril^®) up to 33 ml/kg/day, followed by human albumin 5% up to a total dose (HES 200/0.5 + albumin) of 70 ml/kg/day (n = 15). Additionally FFP was allowed if required. Blood coagulation was monitored using standard coagulation tests, FVIII:C, vWF:Ag, and thrombelastography.

Results

The two study groups did not differ regarding demographic data, initial GCS (A vs B; mean 7.7 vs 8.0), other baseline scores (Apache II, SAPS II, ISS, Marshall Trauma Score, modif. MOF), ICU and hospital days, and mortality rate (4/16 vs 3/15). A mean total of 19 l HES 130/0.4 (range 6-66 l) vs 22 l HES 200/0.5 (6-47 l) + 7 l albumin (1-15 l) were infused. Usage of RBC, platelets, FFP, and fibrinogen was not different between groups. Intracranial bleeding complications (5/16 vs 5/15 patients) were not accompanied by any coagulation disorder but related to the underlying cerebral trauma. In the HES 130/0.4 group ventilation days (mean 9.6 vs 15.7, P < 0.01), colloid treatment days (6.3 vs 11.3, P < 0.01), and number of patients with ICP increase > 35 mmHg (3/16 vs 12/15, P < 0.01) were significantly reduced (Wilcoxon-2-sample test).

Conclusions

Up to 70 ml/kg/day HES 130/0.4 (6%) can be used over several days without compromising blood coagulation or causing bleeding complications in CCT. Possible benefits are reduced ventilation days, lower frequency of ICP peaks, and the avoidance of human albumin.