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

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ClinicalTrials.gov Identifier: NCT00152685
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 9, 2005
Last Update Posted : December 1, 2005
Sponsor:
Information provided by:
University Hospital, Angers

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Head Injury Drug: human serum albumin Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction of the daily median value of intracranial pressure

Eligibility Criteria
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Information from the National Library of Medicine

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

Locations
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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
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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
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ClinicalTrials.gov Identifier: NCT00152685    
Other Study ID Numbers: CP 02-04
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases