NCT00452036

Brief Summary

The objective of this prospective study is to evaluate the reliability of plain x-rays vs.cranial computed tomography as a screening method for skull fractures and its prognostic value for intracranial bleeding (ICB).

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

Longer than P75 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

December 1, 2004

Completed
2.3 years 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
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

First QC Date

March 23, 2007

Last Update Submit

July 26, 2010

Conditions

Keywords

risk factorsplain x raycranial computed tomographyminor head injury

Study Arms (2)

Minor head injury

patients with minor head injury

minor head injury

patients with minor head injury

Eligibility Criteria

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

Consecutive patients seen in the trauma outpatient area

You may qualify if:

  • head injury, nausea, vomiting

You may not qualify if:

  • no head injury

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 (5)

  • Stiell IG, Lesiuk H, Wells GA, McKnight RD, Brison R, Clement C, Eisenhauer MA, Greenberg GH, MacPhail I, Reardon M, Worthington J, Verbeek R, Rowe B, Cass D, Dreyer J, Holroyd B, Morrison L, Schull M, Laupacis A; Canadian CT Head and C-Spine Study Group. The Canadian CT Head Rule Study for patients with minor head injury: rationale, objectives, and methodology for phase I (derivation). Ann Emerg Med. 2001 Aug;38(2):160-9. doi: 10.1067/mem.2001.116796.

    PMID: 11468612BACKGROUND
  • Stiell IG, Lesiuk H, Wells GA, Coyle D, McKnight RD, Brison R, Clement C, Eisenhauer MA, Greenberg GH, Macphail I, Reardon M, Worthington J, Verbeek R, Rowe B, Cass D, Dreyer J, Holroyd B, Morrison L, Schull M, Laupacis A; Canadian CT Head and C-Spine Study Group. Canadian CT head rule study for patients with minor head injury: methodology for phase II (validation and economic analysis). Ann Emerg Med. 2001 Sep;38(3):317-22. doi: 10.1067/mem.2001.116795.

    PMID: 11524653BACKGROUND
  • Stiell IG, Wells GA, Vandemheen KL, Clement CM, Lesiuk H, De Maio VJ, Laupacis A, Schull M, McKnight RD, Verbeek R, Brison R, Cass D, Dreyer J, Eisenhauer MA, Greenberg GH, MacPhail I, Morrison L, Reardon M, Worthington J. The Canadian C-spine rule for radiography in alert and stable trauma patients. JAMA. 2001 Oct 17;286(15):1841-8. doi: 10.1001/jama.286.15.1841.

    PMID: 11597285BACKGROUND
  • Haydel MJ, Preston CA, Mills TJ, Luber S, Blaudeau E, DeBlieux PM. Indications for computed tomography in patients with minor head injury. N Engl J Med. 2000 Jul 13;343(2):100-5. doi: 10.1056/NEJM200007133430204.

    PMID: 10891517BACKGROUND
  • Miller EC, Holmes JF, Derlet RW. Utilizing clinical factors to reduce head CT scan ordering for minor head trauma patients. J Emerg Med. 1997 Jul-Aug;15(4):453-7. doi: 10.1016/s0736-4679(97)00071-1.

    PMID: 9279694BACKGROUND

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Harald C. Wolf, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 26, 2007

Study Start

December 1, 2004

Study Completion

July 1, 2010

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations