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