Diagnostic Algorithm in Patients With Minor Head Injury

NCT ID: NCT00452036

Last Updated: 2010-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Minor Head Injury Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Minor head injury

patients with minor head injury

No interventions assigned to this group

minor head injury

patients with minor head injury

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* head injury, nausea, vomiting

Exclusion Criteria

* no head injury
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Department for Trauma Surgery

Principal Investigators

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Harald C. Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Department for Traumatology/Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 11468612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11524653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11597285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10891517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9279694 (View on PubMed)

Other Identifiers

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HW2

Identifier Type: -

Identifier Source: org_study_id

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