Hemothorax; TraumaticNCT04098185
Role of Pleural Fluid Attenuation Value on CT as a Diagnostic Tool in Traumatic Hemothorax
An observational study of Hemothorax; Traumatic, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemothorax; Traumatic
- What is being tested?
- CT
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients above 18 years old with history of blunt chest trauma and hemodynamically unstable.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Pleural Fluid Attenuation Value Measurement on Computed Tomography as a Diagnostic Tool for Hemothorax in Traumatic Patients
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.
Read the detailed description
Hemothorax is defined as blood accumulation in the pleural space. It is a consequence of blunt trauma in 90% of cases. Hemothorax due to blunt trauma mechanisms e.g traffic accidents,sport accidents and falls are among the commonest injuries of the chest. It is manifested in 30-50% of chest trauma cases. In such cases, bleeding might be caused by damage to pulmonary parenchyma or intercostal arteries associated with or without rib fractures and other chest wall tissue injuries including parietal pleura or other thoracic structures. Although other pleural effusion types may also manifest such as chylothorax in case of chest trauma, however fluid detected in pleural space is usually considered blood unless proven not to be. Despite the clinical and radiological findings provide important data about the content of pleural cavity, however tube thoracostomy and diagnostic thoracocentesis are still required to relieve pressure and characterize the fluid. Tube thoracostomy is an invasive procedure which can lead to immediate procedural injuries, infections and pain which can contribute to respiratory failure in patients with chest wall injury. Although needle thoracocentesis is less invasive than tube thoracostomy, however it carries small but definitive risks such as pneumothorax, bleeding and chest wall hematoma. Since hemothorax is a potentially life threatening, it must be diagnosed quickly and accurately and all these unnecessary complications should be avoided. Chest computed tomography [CT] has been accepted as the gold standard imaging study for evaluating chest trauma and usually performed in patients with grossly severe chest trauma, as it helps to detect even small hemothorax.
CT can also allow for more advanced characterization of pleural fluid and distinguish hemothorax from any other types of effusion by means of scaling Hounsfield units as in literature, any attenuation value for pleural fluid between 35 and 70 HU is considered typically blood, so it can be considered as an important non-invasive diagnostic tool for diagnosis of hemothorax in traumatic patients.
- Conditions
- Hemothorax; Traumatic
- Being tested
- CT
- Medical subject headings
- Hemothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 1 December 2019 to 1 December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hemothorax; TraumaticStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Abdelazem Abdelbary, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098185
- Sponsor's protocol ID
- CT in traumatic hemothorax
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27287951Meyer DM. Hemothorax related to trauma. Thorac Surg Clin. 2007 Feb;17(1):47-55. doi: 10.1016/j.thorsurg.2007.02.006.
PubMed 17650696Sangster 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.
PubMed 17623115Miller 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.
PubMed 16500204Mirvis 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.
PubMed 16274001Hooper 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.
PubMed 20696692Romero 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.
PubMed 24559752Kaewlai 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.
PubMed 18936021Gordon 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.
PubMed 20177035Liu 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.
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.
PubMed 24836489Bolus 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.
PubMed 28132073
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pleural Fluid Attenuation Value Measurement on Computed Tomography as a Diagnostic Tool for Hemothorax in Traumatic Patients
- ClinicalTrials.gov ID
- NCT04098185
- Acronym / sponsor ID
- CT in traumatic hemothorax
- Conditions
- Hemothorax; Traumatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hemothorax is defined as blood accumulation in the pleural space. It is a consequence of blunt trauma in 90% of cases. Hemothorax due to blunt trauma mechanisms e.g traffic accidents,sport accidents and falls are among the commonest injuries of the chest. It is manifested in 30-50% of chest trauma cases. In such cases, bleeding might be caused by damage to pulmonary parenchyma or intercostal arteries associated with or without rib fractures and other chest wall tissue injuries including parietal pleura or other thoracic structures. Although other pleural effusion types may also manifest such as chylothorax in case of chest trauma, however fluid detected in pleural space is usually considered blood unless proven not to be. Despite the clinical and radiological findings provide important data about the content of pleural cavity, however tube thoracostomy and diagnostic thoracocentesis are still required to relieve pressure and characterize the fluid. Tube thoracostomy is an invasive procedure which can lead to immediate procedural injuries, infections and pain which can contribute to respiratory failure in patients with chest wall injury. Although needle thoracocentesis is less invasive than tube thoracostomy, however it carries small but definitive risks such as pneumothorax, bleeding and chest wall hematoma. Since hemothorax is a potentially life threatening, it must be diagnosed quickly and accurately and all these unnecessary complications should be avoided. Chest computed tomography [CT] has been accepted as the gold standard imaging study for evaluating chest trauma and usually performed in patients with grossly severe chest trauma, as it helps to detect even small hemothorax.
CT can also allow for more advanced characterization of pleural fluid and distinguish hemothorax from any other types of effusion by means of scaling Hounsfield units as in literature, any attenuation value for pleural fluid between 35 and 70 HU is considered typically blood, so it can be considered as an important non-invasive diagnostic tool for diagnosis of hemothorax in traumatic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above 18 years old with history of blunt chest trauma and hemodynamically unstable.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTNon-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. | Device | – |
Primary outcome
Role of pleural fluid attenuation value measurement on CT as a diagnostic tool for traumatic hemothorax
Time frame: from 1 December 2019 to 1 December 2020
Measurements of pleural effusion attenuation value on CT to diagnose traumatic hemothorax and differentiate it from other types of pleural effusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Background: PubMed 27287951Sridhar 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.
- Background: PubMed 17650696Meyer DM. Hemothorax related to trauma. Thorac Surg Clin. 2007 Feb;17(1):47-55. doi: 10.1016/j.thorsurg.2007.02.006.
- Background: PubMed 17623115Sangster 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.
- Background: PubMed 16500204Miller 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.
- Background: PubMed 16274001Mirvis 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.
- Background: PubMed 20696692Hooper 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.
- Background: PubMed 24559752Romero 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.
- Background: PubMed 18936021Kaewlai 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.
- Background: PubMed 20177035Gordon 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.
- BackgroundLiu 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: PubMed 24836489Cummings 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.
- Background: PubMed 28132073Bolus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemothorax; Traumatic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada Abdelazem Abdelbary, Dr (00201098815249, khalid.kamal1987@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of pleural fluid attenuation value measurement on CT as a diagnostic tool for traumatic hemothorax (time frame: from 1 December 2019 to 1 December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098185, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.