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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00152685
First received: September 7, 2005
Last updated: November 29, 2005
Last verified: September 2005
History of Changes
  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 Blind

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00152685     History of Changes
Other Study ID Numbers: CP 02-04
Study First Received: September 7, 2005
Last Updated: November 29, 2005
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013