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

Phase 2

• Conditions: Severe Head Injury

• Registration Number: NCT00152685
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Last Update Submitted: 2005-11-29
• Last Update Posted: 2005-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction of the daily median value of intracranial pressure

Trial Locations

Locations (3)

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, France