NCT00228111

Brief Summary

The aim of this study is to establish the additional effectiveness and costs of routine thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 24, 2009

Status Verified

September 1, 2009

Enrollment Period

3 years

First QC Date

August 22, 2005

Last Update Submit

September 23, 2009

Conditions

Keywords

Computed tomographywounds and injuries,non penetratingalgorithmsBlunt trauma of the thorax and abdomen

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult blunt trauma patients

You may qualify if:

  • Patients with life threatening vital problems: respiratory, circulatory (pulse \> 120/min, blood pressure \< 100 mmHg, refill \> 4 sec, exterior blood loss \> 500 ml) or neurologically (Glasgow Coma Score \< 14, abnormal pupils) compromised patients.
  • Patients with a revised trauma score under 12
  • Patients with signs of fractures from at least two long bones
  • Patients with clinical signs of flail chest/multiple rib fractures
  • Patients with a clinically evident pelvic rim fracture
  • Patients with signs of unstable vertebral fractures or signs of neural cord compression
  • Patients involved in a high-energy injury mechanism
  • Fall from height (\> 3 m)
  • As declared by prehospital emergency medical services

You may not qualify if:

  • Patients suffering from a shock Class IIIB/IV
  • Patients who need immediate neurosurgical intervention
  • Pregnant patients
  • Patients referred from other hospitals
  • Patients who die at the emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (4)

  • Brink M, Deunk J, Dekker HM, Kool DR, Edwards MJ, van Vugt AB, Blickman JG. Added value of routine chest MDCT after blunt trauma: evaluation of additional findings and impact on patient management. AJR Am J Roentgenol. 2008 Jun;190(6):1591-8. doi: 10.2214/AJR.07.3277.

  • Deunk J, Brink M, Dekker HM, Kool DR, van Kuijk C, Blickman JG, van Vugt AB, Edwards MJ. Routine versus selective computed tomography of the abdomen, pelvis, and lumbar spine in blunt trauma: a prospective evaluation. J Trauma. 2009 Apr;66(4):1108-17. doi: 10.1097/TA.0b013e31817e55c3.

  • Brink M, Deunk J, Dekker HM, Edwards MJ, Kool DR, van Vugt AB, van Kuijk C, Blickman JG. Criteria for the selective use of chest computed tomography in blunt trauma patients. Eur Radiol. 2010 Apr;20(4):818-28. doi: 10.1007/s00330-009-1608-y. Epub 2009 Sep 17.

  • Brink M, de Lange F, Oostveen LJ, Dekker HM, Kool DR, Deunk J, Edwards MJ, van Kuijk C, Kamman RL, Blickman JG. Arm raising at exposure-controlled multidetector trauma CT of thoracoabdominal region: higher image quality, lower radiation dose. Radiology. 2008 Nov;249(2):661-70. doi: 10.1148/radiol.2492080169.

MeSH Terms

Conditions

Abdominal InjuriesThoracic InjuriesWounds and Injuries

Study Officials

  • A.B. van Vugt, MD, PhD

    Radboud University, Dept. of Traumatology

    STUDY DIRECTOR
  • J.G. Blickman, MD, PhD

    Radboud University, Dept. of Radiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2005

First Posted

September 28, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

September 24, 2009

Record last verified: 2009-09

Locations