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Comparative trial between HyperHAES (7.2% sodio cloruro / 6% hydrxyethyl starch) and 20% mannitol for treatmenti intracranial hypertension in traumatic brain injury - OsmoBrain

Comparative trial between HyperHAES (7.2% sodio cloruro / 6% hydrxyethyl starch) and 20% mannitol for treatmenti intracranial hypertension in traumatic brain injury - OsmoBrain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002005-45-IT
Enrollment
Unknown
Registered
2007-05-09
Start date
2007-05-11
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Brain trauma MedDRA version: 6.1 Level: SOC Classification code 10029205

Interventions

Trade Name: HYPERHAES Pharmaceutical Form: Solution for infusion CAS Number: 9005-27-0 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 110- CAS Number: 764

Sponsors

A.O. San Gerardo di Monza
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Brain trauma with ICP monitoring 2. Intracranial hypertension Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: Intracranial pressure reduction (time spend under threshold ICP <20 mmHg);Secondary Objective: Effects on osmolality and natremia;Primary end point(s): Intracranial pressure reduction (time spend under threshold ICP <20 mmHg)—

Countries

Italy

Outcome results

None listed

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