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

Information source: University Hospital, Angers
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Head Injury

Intervention: human serum albumin (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: University Hospital, Angers

Official(s) and/or principal investigator(s):
Ter Minassian Aram, MD, PhD, Principal Investigator, Affiliation: Universitary hospital of Angers
Audibert Gérard, MD, PhD, Study Chair, Affiliation: Universitary hospital of Nancy
Vigue Bernard, MD, PhD, Study Chair, Affiliation: Universitary hospital of Le Kremlin Bicêtre

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


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.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind

Primary outcome: Reduction of the daily median value of intracranial pressure


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Locations and Contacts

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

Neurosurgical intensive care. CHU Le Kremlin Bicêtre, Le Kremlin Bicêtre 94275, France; Not yet recruiting
Vigue Bernard, Phone: 33 (0)1 45213441, Email: bernard.vigue@bct.ap-hop-paris.fr
Vigue Bernard, MD, PhD, Principal Investigator

Neurosurgical intensive care. CHU de Nancy, Nancy 54035, France; Recruiting
Audibert Gérard, MD, PhD, Phone: 33 (0)3 83 85 14 03, Email: g.audibert@chu-nancy.fr
Audibert Gérard, Md, PhD, Principal Investigator

Surgical intensive care. CHU, Angers, Cedex 9 49993, France; Recruiting
ter Minassian Aram, MD, PhD, Phone: 33 (0)2 4135 39 51, Email: arterminassian@chu-angers.fr
Ter Minassian Aram, MD, PhD, Principal Investigator

Additional Information

Last updated: November 29, 2005

Page last updated: August 23, 2015

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