Diagnostic Algorithm in Patients With Minor Head Injury

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00452036
Collaborator
(none)
12,500
1
67
186.7

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    12500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prospective Study to Find a Diagnostic Algorithm for Diagnosis of Minor Head Injury
    Study Start Date :
    Dec 1, 2004
    Actual Study Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Minor head injury

    patients with minor head injury

    minor head injury

    patients with minor head injury

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • head injury, nausea, vomiting
      Exclusion Criteria:
      • no head injury

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00452036
      Other Study ID Numbers:
      • HW2
      First Posted:
      Mar 26, 2007
      Last Update Posted:
      Jul 27, 2010
      Last Verified:
      Jul 1, 2010

      Study Results

      No Results Posted as of Jul 27, 2010