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

Severe Head Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00152685
• Other study ID #: CP 02-04
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 7, 2005
• Last updated: November 29, 2005

Study information

• Verified date: September 2005
• Source: University Hospital, Angers
• Contact: Ter Minassian Aram, MD, PhD
• Phone: 33 (0)2 41353951
• Email: arterminassian[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Severe Head Injury

Intervention

Drug:
• human serum albumin

Locations

Country	Name	City	State
France	Surgical intensive care. CHU	Angers	Cedex 9
France	Neurosurgical intensive care. CHU Le Kremlin Bicêtre	Le Kremlin Bicêtre
France	Neurosurgical intensive care. CHU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the daily median value of intracranial pressure