Head TraumaMHINCT00622778
Immunemodulation in Patients With Minor Head Injury
An observational study of Head Trauma, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Head Trauma
- How many people
- 130 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2007to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from daily practice
Who may be able to join
- minor head injury
Who cannot join
- severe head injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Algorithm in Minor Head Injury
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.
- Conditions
- Head Trauma
- Keywords
- intracranial bleeding, computed tomography scan
- Medical subject headings
- Craniocerebral Trauma, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients from daily practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial Haematoma
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Vilmos Vecsei, M.D. Professor, Study chair, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622778
- Sponsor's protocol ID
- 3-Wolf
- Acronym
- MHI
- Status last verified
- Jul 2011
- First submitted
- 13 Feb 2008
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/00024382-200303000-00001.
PubMed 12630517Pelinka 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.
PubMed 12744484Pelinka 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.
PubMed 15684648Wolf 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.
PubMed 23451906
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Algorithm in Minor Head Injury
- ClinicalTrials.gov ID
- NCT00622778
- Acronym / sponsor ID
- MHI / 3-Wolf
- Conditions
- Head Trauma
- Keywords
- intracranial bleeding, computed tomography scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients from daily practice |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from daily practice
Key inclusion criteria (1 listed)
- minor head injury
Key exclusion criteria (1 listed)
- severe head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intracranial Haematoma
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- Background: PubMed 12630517Pelinka 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.
- Background: PubMed 12744484Pelinka 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.
- Background: PubMed 15684648Pelinka 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.
- Derived from this study: PubMed 23451906Wolf 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.
Related trials for Head Trauma
Not yet recruiting
The PIONEER Comparative Effectiveness Study - Project 2
Head Injury Trauma, Traumatic Brain Injury, Mild
Not yet recruitingPhase 4
Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
Concussion Post Syndrome, Head Trauma Injury
Recruiting
TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
Mild Traumatic Brain Injury, Intracranial Lesions
Not yet recruiting
Kids Injury Detection Study Using the i-STAT
Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilmos Vecsei, M.D. Professor study chair
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Trauma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Haematoma (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00622778, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012; AzTrials last refreshed its copy on 26 Oct 2026.