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

November 29, 2005 updated by: University Hospital, Angers

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.

Study Overview

Status

Unknown

Conditions

Severe Head Injury

Intervention / Treatment

Drug: human serum albumin

Study Type

Interventional

Enrollment

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Le Kremlin Bicêtre, France, 94275
    - Not yet recruiting
    - Neurosurgical intensive care. CHU Le Kremlin Bicêtre
    - Contact:
      
      Vigue Bernard
      
      Phone Number: 33 (0)1 45213441
      
      Email: bernard.vigue@bct.ap-hop-paris.fr
    - Principal Investigator:
      
      Vigue Bernard, MD, PhD
  - Nancy, France, 54035
    - Recruiting
    - Neurosurgical intensive care. CHU de Nancy
    - Contact:
      
      Audibert Gérard, MD, PhD
      
      Phone Number: 33 (0)3 83 85 14 03
      
      Email: g.audibert@chu-nancy.fr
    - Principal Investigator:
      
      Audibert Gérard, Md, PhD
- Cedex 9
  - Angers, Cedex 9, France, 49993
    - Recruiting
    - Surgical intensive care. CHU
    - Contact:
      
      ter Minassian Aram, MD, PhD
      
      Phone Number: 33 (0)2 4135 39 51
      
      Email: arterminassian@chu-angers.fr
    - Principal Investigator:
      
      Ter Minassian Aram, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of the daily median value of intracranial pressure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

Principal Investigator: Ter Minassian Aram, MD, PhD, Universitary Hospital of Angers
Study Chair: Audibert Gérard, MD, PhD, Universitary hospital of Nancy
Study Chair: Vigue Bernard, MD, PhD, Universitary hospital of Le Kremlin Bicêtre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

December 1, 2005

Last Update Submitted That Met QC Criteria

November 29, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CP 02-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.