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Sports Injury |
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Clinical Trial: High Dose Hyperoncotic Serum Albumin for the Treatment of the Acute Phase of Severe Head Injury.
This study is currently recruiting patients.
Verified by University Hospital Angers September 2005
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Purpose
Experimentaly 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 II Phase III |
MedlinePlus related topics: Head and Brain Injuries
Study Type: Interventional
Study Design: Randomized, Single Blind, Active Control, Single Group Assignment
Further Study Details:
Primary Outcomes: Reduction of the daily median value of intracranial pressure
Expected Total Enrollment: 40
Expected Total Enrollment: 40
Eligibility
Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00152685
Ter Minassian Aram, MD, PhD 33 (0)2 41353951 arterminassian@chu-angers.fr
France
Neurosurgical intensive care. CHU de Nancy, Nancy, 54035, France; Recruiting
Audibert Gérard, MD, PhD 33 (0)3 83 85 14 03 g.audibert@chu-nancy.fr
Audibert Gérard, Md, PhD, Principal Investigator
Audibert Gérard, Md, PhD, Principal Investigator
Neurosurgical intensive care. CHU Le Kremlin Bicêtre, Le Kremlin Bicêtre, 94275, France; Not yet recruiting
Vigue Bernard 33 (0)1 45213441 bernard.vigue@bct.ap-hop-paris.fr
Vigue Bernard, MD, PhD, Principal Investigator
Vigue Bernard, MD, PhD, Principal Investigator
France, CEDEX 9
Surgical intensive care. CHU, Angers, CEDEX 9, 49993, France; Recruiting
ter Minassian Aram, MD, PhD 33 (0)2 4135 39 51 arterminassian@chu-angers.fr
Ter Minassian Aram, MD, PhD, Principal Investigator
Ter Minassian Aram, MD, PhD, Principal Investigator
Study chairs or principal investigators
Ter Minassian Aram, MD, PhD, Principal Investigator, Universitary hospital of Angers
Audibert Gérard, MD, PhD, Study Chair, Universitary hospital of Nancy
Vigue Bernard, MD, PhD, Study Chair, Universitary hospital of Le Kremlin Bicêtre
More Information
Study ID Numbers: CP 02-04
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152685
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152685
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Achilles Tendon (American Academy of Orthopaedic Surgeons)
- Athletic Shoes (American Academy of Orthopaedic Surgeons)
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