NCT00152685

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

December 1, 2005

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

November 29, 2005

Conditions

Severe Head Injury

Outcome Measures

Primary Outcomes (1)

  • Reduction of the daily median value of intracranial pressure

Interventions

human serum albuminDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Surgical intensive care. CHU

Angers, Cedex 9, 49993, France

RECRUITING

Neurosurgical intensive care. CHU Le Kremlin Bicêtre

Le Kremlin-Bicêtre, 94275, France

NOT YET RECRUITING

Neurosurgical intensive care. CHU de Nancy

Nancy, 54035, France

RECRUITING

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Ter Minassian Aram, MD, PhD

    Universitary hospital of Angers

    PRINCIPAL INVESTIGATOR

  • Audibert Gérard, MD, PhD

    Universitary hospital of Nancy

    STUDY CHAIR

  • Vigue Bernard, MD, PhD

    Universitary hospital of Le Kremlin Bicêtre

    STUDY CHAIR

Central Study Contacts

Ter Minassian Aram, MD, PhD

CONTACT

33 (0)2 41353951arterminassian@chu-angers.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Last Updated

December 1, 2005

Record last verified: 2005-09

Locations

FR(3)