NCT00622778

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 11, 2012

Status Verified

July 1, 2011

Enrollment Period

3.6 years

First QC Date

February 13, 2008

Last Update Submit

April 10, 2012

Conditions

Head Trauma

Keywords

intracranial bleedingcomputed tomography scan

Outcome Measures

Primary Outcomes (1)

  • Intracranial Haematoma

    2 weeks

Study Arms (1)

1

Patients from daily practice

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from daily practice

You may qualify if:

  • minor head injury

You may not qualify if:

  • severe head injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (4)

  • 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. doi: 10.1097/00024382-200303000-00001.

    PMID: 12630517BACKGROUND

  • 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. doi: 10.1097/01.shk.0000055345.58165.52.

    PMID: 12744484BACKGROUND

  • 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. doi: 10.1089/neu.2004.21.1553.

    PMID: 15684648BACKGROUND

  • Wolf H, Frantal S, Pajenda GS, Salameh O, Widhalm H, Hajdu S, Sarahrudi K. Predictive value of neuromarkers supported by a set of clinical criteria in patients with mild traumatic brain injury: S100B protein and neuron-specific enolase on trial: clinical article. J Neurosurg. 2013 Jun;118(6):1298-303. doi: 10.3171/2013.1.JNS121181. Epub 2013 Mar 1.

    PMID: 23451906DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum from peripheral blood

MeSH Terms

Conditions

Craniocerebral TraumaIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vilmos Vecsei, M.D. Professor

    Head of Department

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 25, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

April 11, 2012

Record last verified: 2011-07

Locations

AU(1)