NCT04098185

Brief Summary

To define the potential role of pleural fluid attenuation value determined on computed tomography (CT) for diagnosis of traumatic hemothorax and differentiate it from other pleural effusion.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Status
unknown

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

First Submitted

Initial submission to the registry

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 19, 2019

Last Update Submit

September 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Role of pleural fluid attenuation value measurement on CT as a diagnostic tool for traumatic hemothorax

    Measurements of pleural effusion attenuation value on CT to diagnose traumatic hemothorax and differentiate it from other types of pleural effusion.

    from 1 December 2019 to 1 December 2020

Interventions

CTDEVICE

Non-contrast Multidetector Computed Tomography will be done for all patients using 16 or 64 MDCT scanner. Standard scanning parameters of chest CT are used with slice thickness 5 mm, 120kv and automated mAs.The evaluation of pleural effusion attenuation will be done using the average measure of 3 slices with greatest amount of fluid. A region of interest (ROI) is placed for measurement of Hounsfield unit values, where pleural fluid is observed to be most intense and the density values of the pleural fluid and of the aorta are quantitatively measured in the same section with taking care not to involve adjacent ribs, lung parenchyma or areas of pleural thickening.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients above 18 years old with history of blunt chest trauma and hemodynamically unstable.

You may qualify if:

  • All patients above 18 years old
  • History of blunt chest trauma
  • Having mild to moderate effusion
  • CT chest within 1st 24 hours of trauma
  • Patients underwent tube thoracostomy or thoracocentesis

You may not qualify if:

  • Patients in need of emergency transfer to surgery.
  • Hemodynamically stable.
  • Patients with penetrating trauma.
  • Patients with no need for tube thoracostomy or thoracocentesis.
  • Patients with minimal effusion.
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Sridhar S, Raptis C, Bhalla S. Imaging of Blunt Thoracic Trauma. Semin Roentgenol. 2016 Jul;51(3):203-14. doi: 10.1053/j.ro.2015.12.002. Epub 2015 Dec 18. No abstract available.

    PMID: 27287951BACKGROUND
  • Meyer DM. Hemothorax related to trauma. Thorac Surg Clin. 2007 Feb;17(1):47-55. doi: 10.1016/j.thorsurg.2007.02.006.

    PMID: 17650696BACKGROUND
  • Sangster GP, Gonzalez-Beicos A, Carbo AI, Heldmann MG, Ibrahim H, Carrascosa P, Nazar M, D'Agostino HB. Blunt traumatic injuries of the lung parenchyma, pleura, thoracic wall, and intrathoracic airways: multidetector computer tomography imaging findings. Emerg Radiol. 2007 Oct;14(5):297-310. doi: 10.1007/s10140-007-0651-8. Epub 2007 Jul 11.

    PMID: 17623115BACKGROUND
  • Miller LA. Chest wall, lung, and pleural space trauma. Radiol Clin North Am. 2006 Mar;44(2):213-24, viii. doi: 10.1016/j.rcl.2005.10.006.

    PMID: 16500204BACKGROUND
  • Mirvis SE. Imaging of acute thoracic injury: the advent of MDCT screening. Semin Ultrasound CT MR. 2005 Oct;26(5):305-31. doi: 10.1053/j.sult.2005.08.001.

    PMID: 16274001BACKGROUND
  • Hooper C, Lee YC, Maskell N; BTS Pleural Guideline Group. Investigation of a unilateral pleural effusion in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii4-17. doi: 10.1136/thx.2010.136978. No abstract available.

    PMID: 20696692BACKGROUND
  • Romero M, Bachler P. Pseudo-hemothorax at computed tomography due to residual contrast media. Clin Imaging. 2014 May-Jun;38(3):333-5. doi: 10.1016/j.clinimag.2014.01.004. Epub 2014 Jan 16.

    PMID: 24559752BACKGROUND
  • Kaewlai R, Avery LL, Asrani AV, Novelline RA. Multidetector CT of blunt thoracic trauma. Radiographics. 2008 Oct;28(6):1555-70. doi: 10.1148/rg.286085510.

    PMID: 18936021BACKGROUND
  • Gordon CE, Feller-Kopman D, Balk EM, Smetana GW. Pneumothorax following thoracentesis: a systematic review and meta-analysis. Arch Intern Med. 2010 Feb 22;170(4):332-9. doi: 10.1001/archinternmed.2009.548.

    PMID: 20177035BACKGROUND
  • Liu F, Huang YC, Ng YB, Liang JH. Differentiatepleural effusion from hemothorax after bluntchest trauma; comparison of computed tomography attenuation values. Journal of AcuteMedicine 2016; 6: 1-6.

    BACKGROUND
  • Cummings KW, Javidan-Nejad C, Bhalla S. Multidetector computed tomography of nonosseous thoracic trauma. Semin Roentgenol. 2014 Apr;49(2):134-42. doi: 10.1053/j.ro.2014.01.002. Epub 2014 Jan 28. No abstract available.

    PMID: 24836489BACKGROUND
  • Bolus D, Morgan D, Berland L. Effective use of the Hounsfield unit in the age of variable energy CT. Abdom Radiol (NY). 2017 Mar;42(3):766-771. doi: 10.1007/s00261-017-1052-4.

    PMID: 28132073BACKGROUND

MeSH Terms

Conditions

Hemothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ghada Abdelazem Abdelbary, Dr

CONTACT

Eman proffesor Abo Elhamd, Prof Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Diagnostic Radiology

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

September 24, 2019

Record last verified: 2019-09