Rogaland Trauma System Study | NCT00876564

Studies
Rogaland Trauma System Study

NCT00876564

Sponsor

Norwegian Air Ambulance Foundation

Status

Completed

Last Update Posted

May 8, 2013Estimated

Enrollment

1,812Actual

Phase

Not Applicable

Conditions

Trauma

Interventions

Trauma patients

Countries

Norway

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

ID	Type	Description	Link
2009/228-CAG(REK)

Status Module

Record Verification Date

May 2013

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

Feb 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 3, 2009

First Posted Date

Apr 6, 2009Estimated

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

May 7, 2013

Last Update Posted Date

May 8, 2013Estimated

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 purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Through a before and after study, the investigators aim to measure how the quality improvement initiative will influence structure, process and outcomes variables.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,812Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trauma patients	Other	Included in trauma registry	Other: Trauma patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trauma patients	Other		Trauma patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	Over and undertriage	7 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Included in trauma registry

Exclusion Criteria:

Excluded from trauma registry

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marius Rehn, MD	Norwegian Air Ambulance Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stavanger University Hospital		Stavanger	Rogaland	4011	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22190166	Derived	Rehn M, Lossius HM, Tjosevik KE, Vetrhus M, Ostebo O, Eken T; Rogaland Trauma System Study Collaborating Group. Efficacy of a two-tiered trauma team activation protocol in a Norwegian trauma centre. Br J Surg. 2012 Feb;99(2):199-208. doi: 10.1002/bjs.7794. Epub 2011 Dec 20.