High Dose Hyperoncotic Serum Albumin for the Treatment of... | NCT00152685

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

NCT00152685

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Dec 1, 2005Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Severe Head Injury

Interventions

human serum albumin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 9, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2005

Last Update Posted Date

Dec 1, 2005Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
human serum albumin	Drug

Measure	Description	Time Frame
Reduction of the daily median value of intracranial pressure

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ter Minassian Aram, MD, PhD	Contact	33 (0)2 41353951		arterminassian@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Ter Minassian Aram, MD, PhD	Universitary hospital of Angers	Principal Investigator
Audibert Gérard, MD, PhD	Universitary hospital of Nancy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surgical intensive care. CHU	Recruiting	Angers	Cedex 9	49993	France

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000075462	Serum Albumin, Human

Ancestor Terms

ID	Term
D012709	Serum Albumin
D000418	Albumins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided