High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury
Sponsor
University Hospital, Angers (Other)
Overall Status
Unknown status
CT.gov ID
NCT00152685
Collaborator
(none)
40
3
13.3
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Outcome Measures
Primary Outcome Measures
- Reduction of the daily median value of intracranial pressure []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Surgical intensive care. CHU | Angers | Cedex 9 | France | 49993 |
| 2 | Neurosurgical intensive care. CHU Le Kremlin Bicêtre | Le Kremlin Bicêtre | France | 94275 | |
| 3 | Neurosurgical intensive care. CHU de Nancy | Nancy | France | 54035 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00152685
Other Study ID Numbers:
- CP 02-04
First Posted:
Sep 9, 2005
Last Update Posted:
Dec 1, 2005
Last Verified:
Sep 1, 2005
Additional relevant MeSH terms: