The aim of the study is to measure the effects of intraoperatively infused hydroxy-ethyl-starch and gelatin-solution on the coagulation system (fibrinpolymerisation and thrombingeneration) of infants and children in comparison to human albumin.
Conditions
Interventions
Trade Name: Voluven
Product Name: Voluven
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: hyroxyethylstarch 130/0,4 6%
CAS Number: 0009005-27-0
Other descriptive name: HES colloid
Conce
Sponsors
Univ. hospital, Dpt. of anaesthesia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 60 infants and children between 3 and 15 kg BW, undergoing elective major surgery with the need for at least 15 ml/kg intraoperative colloid infusion. Informed consent from the parents. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Preterm babies, underlying coagulation disorders, sepsis, liver- and renal insufficiency, anemia with transfusion requirement from the beginning of surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effects of synthetic colloids (hydroxy-ethyl-starch, gelatin) and human albumin on the coagulation system in 60 infants and children between 3 and 15 kg BW. Thrombelastography and detailed coagulation tests (floxcytometry, fibrinpolymerisation and thrombingeneration) before, after intraoperative infusion of 15 ml/kg colloids, and before transfusion of blood products or coagulation factors.;Secondary Objective: ;Primary end point(s): Changes in hemostasis after colloid infusion compared to baseline within group. Changes in hemostasis between the 3 study-groups. | — |
Countries
Austria
Outcome results
None listed