High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152685

Enrollment

Registered

2005-09-09

Start date

Unknown

Completion date

Unknown

Last updated

2005-12-01

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

Conditions

Severe Head Injury

Brief summary

Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.

Interventions

DRUGhuman serum albumin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* severe head injury (GCS \< 9) Next of kin informed consent

Exclusion criteria

* Cranio cerebral wound Pregnancy Hypoxemia (PaO2/FiO2\< 300 mmHg) Blood loss \> 1/2 blood mass Renal or cardiac failure,uncontrolled hypertension Head injury dating from more than 24 hours at the time of inclusion

Design outcomes

Primary

Measure	Time frame
Reduction of the daily median value of intracranial pressure	—

Countries

France

Contacts

Primary ContactTer Minassian Aram, MD, PhD

arterminassian@chu-angers.fr33 (0)2 41353951

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026