Immunemodulation in Patients With Minor Head Injury (MHI)

This study has been completed.

Sponsor:

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00622778

First received: February 13, 2008

Last updated: April 10, 2012

Last verified: July 2011

History of Changes

Purpose

The purpose of this study is to try to prove the worth of the two (2) Serum Proteins S-100 Beta and NSE in combination with a diagnostic algorithm to help to establish diagnosis in patients with minor head injury.

Condition
Head Trauma

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Diagnostic Algorithm in Minor Head Injury

Resource links provided by NLM:

MedlinePlus related topics: Head Injuries Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Intracranial Haematoma [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Serum from peripheral blood

Enrollment:	130
Study Start Date:	October 2007
Study Completion Date:	July 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients from daily practice

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from daily practice

Criteria

Inclusion Criteria:

minor head injury

Exclusion Criteria:

severe head injury

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622778

Locations

Austria
Medical University of Vienna
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Study Chair:

Vilmos Vecsei, M.D. Professor

Head of Department

More Information

Publications:

Pelinka LE, Toegel E, Mauritz W, Redl H. Serum S 100 B: a marker of brain damage in traumatic brain injury with and without multiple trauma. Shock. 2003 Mar;19(3):195-200.

Pelinka LE, Bahrami S, Szalay L, Umar F, Redl H. Hemorrhagic shock induces an S 100 B increase associated with shock severity. Shock. 2003 May;19(5):422-6.

Pelinka LE, Kroepfl A, Leixnering M, Buchinger W, Raabe A, Redl H. GFAP versus S100B in serum after traumatic brain injury: relationship to brain damage and outcome. J Neurotrauma. 2004 Nov;21(11):1553-61.

Responsible Party:	Dr. Harald Wolf, Department for Trauma Surgery
ClinicalTrials.gov Identifier:	NCT00622778 History of Changes
Other Study ID Numbers:	3-Wolf
Study First Received:	February 13, 2008
Last Updated:	April 10, 2012
Health Authority:	Austria: Medical University of Vienna local Ethics Committee

Keywords provided by Medical University of Vienna:

intracranial bleeding
computed tomography scan

Additional relevant MeSH terms:

Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013

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