The influence of intravascular volume therapy with a new hydroxyethyl starch preparation (6% HES 130/0.4) on coagulation in patients undergoing major abdominal surgery.

UNLABELLED: A new hydroxyethyl starch (HES) preparation with a mean molecular weight of 130,000 daltons and a degree of substitution of 0.4 shows favorable pharmacokinetic properties. We conducted a study of the influence of the new HES specification on coagulation and compared it with another colloidal intravascular volume replacement regimen using gelatin. According to a prospective, random sequence, 42 patients undergoing major abdominal surgery received either HES 130/0.4 (n = 21) or gelatin (n = 21) until the first postoperative day (POD) to keep central venous pressure between 10 and 14 mm Hg. From arterial blood samples, standard coagulation variables were measured, and modified thrombelastogram (TEG) measurements using different activators were performed. A total of 2830 +/- 350 mL of gelatin and 2430 +/- 310 mL of HES 130/0.4 were administered until the morning of the first POD. The use of allogeneic blood/blood products and standard coagulation variables did not differ significantly between the two groups. After induction of anesthesia, all TEG data for both groups were within normal range. Coagulation time and maximum clot firmness did not change significantly in any TEG measurements during the study period. The kinetics of clot formation (clot formation time) significantly increased immediately after surgery, but without showing significant group differences. On the morning of the first POD, the clot formation time returned to almost normal levels, except for aprotinin-activated TEG(R). We conclude that administration of moderate doses of the new HES 130/0.4 preparation in patients undergoing major abdominal surgery results in similar coagulation alterations as those after using an established gelatin-based volume-replacement regimen. IMPLICATIONS: We compared the effects of infusion of a new hydroxyethyl starch preparation (6% hydroxyethyl starch; mean molecular weight 130,000 daltons; degree of substitution 0.4) on coagulation with a gelatin-based intravascular volume replacement regimen in patients undergoing major abdominal surgery. After moderate doses of hydroxyethyl starch (2430 +/- 310 mL until the morning of the first postoperative day), coagulation monitoring, including modified thrombelastography, did not show impaired hemostasis.

RCT Entities:   Population Interventions Outcomes