Clinical trial NCT00452036: Diagnostic Algorithm in Patients With Minor Head Injury
Official title: Prospective Study to Find a Diagnostic Algorithm for Diagnosis of Minor Head Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minor Head Injury
Traumatic Brain Injury
Keywords: risk factors
plain x ray
cranial computed tomography
minor head injury
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-03-26
Enrollment: 12500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients seen in the trauma outpatient area

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).

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 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.

Eligibility criteria: Inclusion Criteria:

* head injury, nausea, vomiting

Exclusion Criteria:

* no head injury

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department for Traumatology/Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Harald C. Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1067/mem.2001.116796.
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. doi: 10.1067/mem.2001.116795.
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. doi: 10.1001/jama.286.15.1841.
citation: 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.
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. doi: 10.1016/s0736-4679(97)00071-1.