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Study on efficacy of Tetraspan on children aged less than 36 months undergoing major surgery - HES Study

Study on efficacy of Tetraspan on children aged less than 36 months undergoing major surgery - HES Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009116-49-IT
Enrollment
Unknown
Registered
2012-03-01
Start date
2009-05-04
Completion date
Unknown
Last updated
2012-03-20

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

Conditions

Major surgery

Interventions

Trade Name: TETRASPAN Pharmaceutical Form: Solution for injection INN or Proposed INN: Hydroxyethylstarch Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 60-

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children scheduled for major surgery, aged less than 36 months 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: Hiperhidratation Renal failure Intracranic haemorragy Epatic failure Cardiac failure

Design outcomes

Primary

MeasureTime frame
Main Objective: Heamodynamic stability after Tetraspan infusion;Secondary Objective: Effect of Tetraspan on: Blood clotting Lactate Plasma electrolitis Acid_base equilibrium Renal function Haepatic function Blood losses Blood transfusion;Primary end point(s): Arterial Pressure mainteinance—

Countries

Italy

Outcome results

None listed

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