Minor Head InjuryNCT00451789
Risk Factors of Minor Head Injury
An observational study of Minor Head Injury and Intracranial Bleeding, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Introduction and Aims: The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Minor Head Injury, Intracranial Bleeding, Traumatic Brain Injury
- How many people
- 12,500 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2004to Apr 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Minor head injury, dizziness, nausea, vomiting
Who cannot join
- no injury to the head
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department for Traumatology/Medical University of Vienna
Vienna, State of Vienna, A-1090
About this study
Official title: Risk Factors of Minor Head Injury in Traumatological Patients
Introduction and Aims:
The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.
Read the detailed description
Minor head injury (MHI)is one of the most common diagnoses in emergency rooms and traumatological outpatient departments. The aim of this study is to find clear evidence which risk factors are the most important in MHI patients to develop intracranial bleeding. We hypothetize that anticoagulation is one of the main risk factors for intracranial bleeding.
- Keywords
- Minor head injury, iintracranial bleeding, traumatic brain injury, Cranial computed tomography, anticoagulatory drugs
- Medical subject headings
- Craniocerebral Trauma, Intracranial Hemorrhages, Brain Injuries, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startDec 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Minor Head InjuryStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 12,500 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang Machold, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451789
- Sponsor's protocol ID
- HW1
- Status last verified
- Mar 2007
- First submitted
- 23 Mar 2007
- Last updated
- 26 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Karni A, Holtzman R, Bass T, Zorman G, Carter L, Rodriguez L, Bennett-Shipman VJ, Lottenberg L. Traumatic head injury in the anticoagulated elderly patient: a lethal combination. Am Surg. 2001 Nov;67(11):1098-100.
PubMed 11730229Wojcik R, Cipolle MD, Seislove E, Wasser TE, Pasquale MD. Preinjury warfarin does not impact outcome in trauma patients. J Trauma. 2001 Dec;51(6):1147-51; discussion 1151-2. doi: 10.1097/00005373-200112000-00021.
PubMed 11740267Wolf H, Machold W, Frantal S, Kecht M, Pajenda G, Leitgeb J, Widhalm H, Hajdu S, Sarahrudi K. Risk factors indicating the need for cranial CT scans in elderly patients with head trauma: an Austrian trial and comparison with the Canadian CT Head Rule. J Neurosurg. 2014 Feb;120(2):447-52. doi: 10.3171/2013.10.JNS13726. Epub 2013 Dec 6.
PubMed 24313609
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Minor Head Injury in Traumatological Patients
- ClinicalTrials.gov ID
- NCT00451789
- Acronym / sponsor ID
- HW1
- Keywords
- Minor head injury, iintracranial bleeding, traumatic brain injury, Cranial computed tomography, anticoagulatory drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,500 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 26 Mar 2007 (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.
Introduction and Aims:
The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.
Detailed description
Minor head injury (MHI)is one of the most common diagnoses in emergency rooms and traumatological outpatient departments. The aim of this study is to find clear evidence which risk factors are the most important in MHI patients to develop intracranial bleeding. We hypothetize that anticoagulation is one of the main risk factors for intracranial bleeding.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Minor head injury, dizziness, nausea, vomiting
Key exclusion criteria (1 listed)
- no injury to the head
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
Not reported in the source record.
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 26 Mar 2007.
- Background: PubMed 11730229Karni A, Holtzman R, Bass T, Zorman G, Carter L, Rodriguez L, Bennett-Shipman VJ, Lottenberg L. Traumatic head injury in the anticoagulated elderly patient: a lethal combination. Am Surg. 2001 Nov;67(11):1098-100.
- Background: PubMed 11740267Wojcik R, Cipolle MD, Seislove E, Wasser TE, Pasquale MD. Preinjury warfarin does not impact outcome in trauma patients. J Trauma. 2001 Dec;51(6):1147-51; discussion 1151-2. doi: 10.1097/00005373-200112000-00021.
- Derived from this study: PubMed 24313609Wolf H, Machold W, Frantal S, Kecht M, Pajenda G, Leitgeb J, Widhalm H, Hajdu S, Sarahrudi K. Risk factors indicating the need for cranial CT scans in elderly patients with head trauma: an Austrian trial and comparison with the Canadian CT Head Rule. J Neurosurg. 2014 Feb;120(2):447-52. doi: 10.3171/2013.10.JNS13726. Epub 2013 Dec 6.
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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.
Wolfgang Machold, MD principal investigator
Medical University of Vienna
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 Minor Head Injury and Intracranial Bleeding, 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 26 Mar 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451789, which also lists 3 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 26 Mar 2007; AzTrials last refreshed its copy on 7 Nov 2026.