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

NCT ID: NCT00152685

Last Updated: 2005-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Severe Head Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Interventions

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human serum albumin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Ter Minassian Aram, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitary hospital of Angers

Audibert Gérard, MD, PhD

Role: STUDY_CHAIR

Universitary hospital of Nancy

Vigue Bernard, MD, PhD

Role: STUDY_CHAIR

Universitary hospital of Le Kremlin Bicêtre

Locations

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Surgical intensive care. CHU

Angers, Cedex 9, France

Site Status RECRUITING

Neurosurgical intensive care. CHU Le Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Site Status NOT_YET_RECRUITING

Neurosurgical intensive care. CHU de Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ter Minassian Aram, MD, PhD

Role: CONTACT

Phone: 33 (0)2 41353951

Email: [email protected]

Facility Contacts

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ter Minassian Aram, MD, PhD

Role: primary

Vigue Bernard

Role: primary

Audibert Gérard, MD, PhD

Role: primary

Other Identifiers

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CP 02-04

Identifier Type: -

Identifier Source: org_study_id