Diagnostic Algorithm in Patients With Minor Head Injury

Traumatic Brain Injury Clinical Trial

Official title:

Prospective Study to Find a Diagnostic Algorithm for Diagnosis of Minor Head Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452036
• Other study ID #: HW2
• Status: Completed
• Phase: N/A
• First received: March 23, 2007
• Last updated: July 26, 2010
• Start date: December 2004
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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).

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 clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12500
• Est. completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• head injury, nausea, vomiting

Exclusion Criteria:

• no head injury

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Minor Head Injury
• Traumatic Brain Injury

Locations

Country	Name	City	State
Austria	Department for Traumatology/Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation