NCT00451789

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

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

December 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2007

Completed
Last Updated

March 26, 2007

Status Verified

March 1, 2007

First QC Date

March 23, 2007

Last Update Submit

March 23, 2007

Conditions

Minor Head InjuryIntracranial BleedingTraumatic Brain Injury

Keywords

Minor head injuryiintracranial bleedingtraumatic brain injuryCranial computed tomographyanticoagulatory drugs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Minor head injury, dizziness, nausea, vomiting

You may not qualify if:

  • no injury to the head

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Traumatology/Medical University of Vienna

Vienna, Vienna, A-1090, Austria

Location

Related Publications (3)

  • 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.

    PMID: 11730229BACKGROUND

  • Wojcik 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.

    PMID: 11740267BACKGROUND

  • Wolf 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.

    PMID: 24313609DERIVED

MeSH Terms

Conditions

Craniocerebral TraumaIntracranial HemorrhagesBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wolfgang Machold, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 26, 2007

Study Start

December 1, 2004

Study Completion

April 1, 2006

Last Updated

March 26, 2007

Record last verified: 2007-03

Locations

AU(1)