Diagnostic Algorithm in Patients With Minor Head Injury | NCT00452036

Studies
Diagnostic Algorithm in Patients With Minor Head Injury

NCT00452036

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jul 27, 2010Estimated

Enrollment

12,500Actual

Phase

Not provided

Conditions

Minor Head Injury
Traumatic Brain Injury

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Jul 2010Actual

First Submitted Date

Mar 23, 2007

First Submission Date that Met QC Criteria

Mar 23, 2007

First Posted Date

Mar 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2010

Last Update Posted Date

Jul 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Minor head injury		patients with minor head injury
minor head injury		patients with minor head injury

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

head injury, nausea, vomiting

Exclusion Criteria:

no head injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive patients seen in the trauma outpatient area

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harald C. Wolf, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Traumatology/Medical University of Vienna		Vienna	State of Vienna	A-1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11468612	Background	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.
11524653

ID	Term
D006259	Craniocerebral Trauma
D000070642	Brain Injuries, Traumatic

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D001930	Brain Injuries