We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152685
First Posted: September 9, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Angers
  Purpose
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.

Condition Intervention Phase
Severe Head Injury Drug: human serum albumin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Reduction of the daily median value of intracranial pressure

Estimated Enrollment: 40
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152685


Contacts
Contact: Ter Minassian Aram, MD, PhD 33 (0)2 41353951 arterminassian@chu-angers.fr

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

ClinicalTrials.gov Identifier: NCT00152685     History of Changes
Other Study ID Numbers: CP 02-04
First Submitted: September 7, 2005
First Posted: September 9, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries