Diagnostic Algorithm in Patients With Minor Head Injury - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00452036

Purpose

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).

Condition
Minor Head Injury Traumatic Brain Injury

MedlinePlus related topics: Traumatic Brain Injury X-Rays

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title:	Prospective Study to Find a Diagnositc Algorithm for Diagnosis of Minor Head Injury

Further study details as provided by Medical University of Vienna:

Estimated Enrollment:	12500
Study Start Date:	December 2004
Estimated Study Completion Date:	April 2007

Detailed Description:

In a consecutive patients series of about 12500, blunt head injuries were observed (during a 16 month period), in a prospective analysis.

Based on a retrospective study, we created a checklist of individual patients data which was completed for each patient.

In accordance with the institutions guidelines all patients with blunt head injury received plain skull x-ray in 2 plains and additional cranial CT-scan (CCT) in case of fracture or neurological symptoms. We developed also an diagnostic algorithm consisting of anamnestical data and clincal signs and symptoms to define these risk factors and to catch all patients with minor head injury who are at risk to develop intracranial bleeding.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

head injury, nausea, vomiting

Exclusion Criteria:

no head injury

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452036

Locations

Austria
Department for Traumatology/Medical University of Vienna
Vienna, Austria, A-1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Harald C. Wolf, MD

Medical University of Vienna

More Information

Publications:

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.

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.

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.

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.

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.

Study ID Numbers:	HW2
Study First Received:	March 23, 2007
Last Updated:	March 23, 2007
ClinicalTrials.gov Identifier:	NCT00452036 History of Changes
Health Authority:	Austria: Ethikkommission

Keywords provided by Medical University of Vienna:

risk factors
plain x ray
cranial computed tomography
minor head injury

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Craniocerebral Trauma
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases

Disorders of Environmental Origin
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on May 07, 2009