This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Information provided by:
University Hospital, Angers Identifier:
First received: September 7, 2005
Last updated: November 29, 2005
Last verified: September 2005
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

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00152685

Contact: Ter Minassian Aram, MD, PhD 33 (0)2 41353951

Surgical intensive care. CHU Recruiting
Angers, Cedex 9, France, 49993
Contact: ter Minassian Aram, MD, PhD    33 (0)2 4135 39 51   
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   
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   
Principal Investigator: Audibert Gérard, Md, PhD         
Sponsors and Collaborators
University Hospital, Angers
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 Identifier: NCT00152685     History of Changes
Other Study ID Numbers: CP 02-04
Study First Received: September 7, 2005
Last Updated: November 29, 2005

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries processed this record on September 19, 2017