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

NCT00152685 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2005-12-01

No results posted yet for this study

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.

Conditions

  • Severe Head Injury

Interventions

DRUG

human serum albumin

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Ter Minassian Aram, MD, PhD · Universitary hospital of Angers

  • Audibert Gérard, MD, PhD · Universitary hospital of Nancy

  • Vigue Bernard, MD, PhD · Universitary hospital of Le Kremlin Bicêtre

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152685 on ClinicalTrials.gov