Plasma sostitution in paediatric neurosurgery: comparison between two sinthetic colloids: HES 130/0,42/6:1 in normal salin solution (Voluven)vs HES 130/0,42/6:1 in balanced electrolitic solution (plasmavolume)
- Conditions
- pediatric patients undergoing major neurosurgical proceduresMedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2010-019421-33-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
pediatric patients undergoing major neurosurgical procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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
no informed consent obtained
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: compare the safety of repetitive large-dose infusion of these two starches in patients undergoing major neurosurgical procedures;Secondary Objective: nd;Primary end point(s): nd
- Secondary Outcome Measures
Name Time Method