Effects of colloids on hemostasis in paediatric anaesthesia - Colloids in paediatric anaesthesia
Phase 1
- Conditions
- 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.
- Registration Number
- EUCTR2004-001610-14-AT
- Lead Sponsor
- niv. hospital, Dpt. of anaesthesia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
Preterm babies, underlying coagulation disorders, sepsis, liver- and renal insufficiency, anemia with transfusion requirement from the beginning of surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method