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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)

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019421-33-IT
Enrollment
100
Registered
2012-03-02
Start date
2012-10-31
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric patients undergoing major neurosurgical procedures MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: PLASMAVOLUME Pharmaceutical Form: Solution for infusion INN or Proposed INN: Hydroxyethylstarch Concentration unit: ml millilitre(s) Concentration number: 20- Trade Name: VOLUVEN Pharmace

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: no informed consent obtained

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactTerapia Intensiva Pediatrica

Policlinico Gemelli

etico@rm.unicatt.it0630155556

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026