MedDataX Logo

CEUS for Blunt Abdominal Trauma in Children

NCT ID: NCT03490929

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT include risks due to radiation exposure and necessity of transport of the patient. Ultrasound without contrast uses safer non-ionizing radiation and can be performed at the bedside, however it has been shown to have variable sensitivity and specificity for identifying intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have shown promise for improving the sensitivity and specificity of this imaging modality.

Hypothesis(es) and Aims:

Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as compared to a gold standard conventional CT scan for the identification of intra-abdominal solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific Aims:

Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in hemodynamically stable children with blunt abdominal trauma

Design:

This will be a prospective cohort study to evaluate the test characteristics of contrast enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or acquired heart disease. Sample size calculations assume a baseline prevalence of disease in approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95% with a two-sided confidence interval precision of 8%, yielding an estimated sample size of 146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS as compared to a gold standard CT scan.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Abdomen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Contrast-enhanced ultrasound arm

contrast-enhanced ultrasound

Group Type EXPERIMENTAL

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]

Intervention Type DRUG

injection of Lumason (ultrasound contrast agent)

contrast-enhanced ultrasound

Intervention Type DEVICE

ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]

injection of Lumason (ultrasound contrast agent)

Intervention Type DRUG

contrast-enhanced ultrasound

ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lumason ultrasound

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)
2. History of or suspicion for blunt abdominal trauma
3. Abdominal CT ordered or obtained

Exclusion Criteria

1. History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
2. Co-existing penetrating abdominal trauma
3. Known congenital or acquired heart disease
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aaron E. Chen

Professor of Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aaron E Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aaron E Chen, MD

Role: CONTACT

[email protected]
2674260383

Rachel Rempell, MD

Role: CONTACT

[email protected]
2155907041

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tobias Kummer, MD

Role: primary

[email protected]
507-255-4732

Derek Vanmeter

Role: backup

[email protected]
5072554732

Aaron E Chen, MD

Role: primary

[email protected]
267-426-0383

References

Explore related publications, articles, or registry entries linked to this study.

Miele V, Piccolo CL, Galluzzo M, Ianniello S, Sessa B, Trinci M. Contrast-enhanced ultrasound (CEUS) in blunt abdominal trauma. Br J Radiol. 2016;89(1061):20150823. doi: 10.1259/bjr.20150823. Epub 2016 Jan 8.

Reference Type BACKGROUND
PMID: 26607647 (View on PubMed)

Armstrong LB, Mooney DP, Paltiel H, Barnewolt C, Dionigi B, Arbuthnot M, Onwubiko C, Connolly SA, Jarrett DY, Zalieckas JM. Contrast enhanced ultrasound for the evaluation of blunt pediatric abdominal trauma. J Pediatr Surg. 2018 Mar;53(3):548-552. doi: 10.1016/j.jpedsurg.2017.03.042. Epub 2017 Mar 20.

Reference Type BACKGROUND
PMID: 28351519 (View on PubMed)

Menichini G, Sessa B, Trinci M, Galluzzo M, Miele V. Accuracy of contrast-enhanced ultrasound (CEUS) in the identification and characterization of traumatic solid organ lesions in children: a retrospective comparison with baseline US and CE-MDCT. Radiol Med. 2015 Nov;120(11):989-1001. doi: 10.1007/s11547-015-0535-z. Epub 2015 Mar 31.

Reference Type BACKGROUND
PMID: 25822953 (View on PubMed)

Cagini L, Gravante S, Malaspina CM, Cesarano E, Giganti M, Rebonato A, Fonio P, Scialpi M. Contrast enhanced ultrasound (CEUS) in blunt abdominal trauma. Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S9. doi: 10.1186/2036-7902-5-S1-S9. Epub 2013 Jul 15.

Reference Type BACKGROUND
PMID: 23902930 (View on PubMed)

Cokkinos D, Antypa E, Stefanidis K, Tserotas P, Kostaras V, Parlamenti A, Tavernaraki K, Piperopoulos PN. Contrast-enhanced ultrasound for imaging blunt abdominal trauma - indications, description of the technique and imaging review. Ultraschall Med. 2012 Feb;33(1):60-7. doi: 10.1055/s-0031-1273442. Epub 2012 Jan 24.

Reference Type BACKGROUND
PMID: 22274907 (View on PubMed)

Afaq A, Harvey C, Aldin Z, Leen E, Cosgrove D. Contrast-enhanced ultrasound in abdominal trauma. Eur J Emerg Med. 2012 Jun;19(3):140-5. doi: 10.1097/MEJ.0b013e328348c980.

Reference Type BACKGROUND
PMID: 21934507 (View on PubMed)

Valentino M, De Luca C, Galloni SS, Branchini M, Modolon C, Pavlica P, Barozzi L. Contrast-enhanced US evaluation in patients with blunt abdominal trauma(). J Ultrasound. 2010 Mar;13(1):22-7. doi: 10.1016/j.jus.2010.06.002. Epub 2010 Jul 8.

Reference Type BACKGROUND
PMID: 23396012 (View on PubMed)

Valentino M, Ansaloni L, Catena F, Pavlica P, Pinna AD, Barozzi L. Contrast-enhanced ultrasonography in blunt abdominal trauma: considerations after 5 years of experience. Radiol Med. 2009 Oct;114(7):1080-93. doi: 10.1007/s11547-009-0444-0. Epub 2009 Sep 22.

Reference Type BACKGROUND
PMID: 19774445 (View on PubMed)

Sivit CJ. Imaging children with abdominal trauma. AJR Am J Roentgenol. 2009 May;192(5):1179-89. doi: 10.2214/AJR.08.2163.

Reference Type BACKGROUND
PMID: 19380540 (View on PubMed)

Catalano O, Aiani L, Barozzi L, Bokor D, De Marchi A, Faletti C, Maggioni F, Montanari N, Orlandi PE, Siani A, Sidhu PS, Thompson PK, Valentino M, Ziosi A, Martegani A. CEUS in abdominal trauma: multi-center study. Abdom Imaging. 2009 Mar-Apr;34(2):225-34. doi: 10.1007/s00261-008-9452-0.

Reference Type BACKGROUND
PMID: 18682877 (View on PubMed)

Clevert DA, Weckbach S, Minaifar N, Clevert DA, Stickel M, Reiser M. Contrast-enhanced ultrasound versus MS-CT in blunt abdominal trauma. Clin Hemorheol Microcirc. 2008;39(1-4):155-69.

Reference Type BACKGROUND
PMID: 18503121 (View on PubMed)

Valentino M, Serra C, Pavlica P, Labate AM, Lima M, Baroncini S, Barozzi L. Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children--initial experience. Radiology. 2008 Mar;246(3):903-9. doi: 10.1148/radiol.2463070652. Epub 2008 Jan 14.

Reference Type BACKGROUND
PMID: 18195385 (View on PubMed)

Bixby SD, Callahan MJ, Taylor GA. Imaging in pediatric blunt abdominal trauma. Semin Roentgenol. 2008 Jan;43(1):72-82. doi: 10.1053/j.ro.2007.08.009. No abstract available.

Reference Type BACKGROUND
PMID: 18053830 (View on PubMed)

Ntoulia A, Anupindi SA, Darge K, Back SJ. Applications of contrast-enhanced ultrasound in the pediatric abdomen. Abdom Radiol (NY). 2018 Apr;43(4):948-959. doi: 10.1007/s00261-017-1315-0.

Reference Type BACKGROUND
PMID: 28980061 (View on PubMed)

Darge K, Papadopoulou F, Ntoulia A, Bulas DI, Coley BD, Fordham LA, Paltiel HJ, McCarville B, Volberg FM, Cosgrove DO, Goldberg BB, Wilson SR, Feinstein SB. Safety of contrast-enhanced ultrasound in children for non-cardiac applications: a review by the Society for Pediatric Radiology (SPR) and the International Contrast Ultrasound Society (ICUS). Pediatr Radiol. 2013 Sep;43(9):1063-73. doi: 10.1007/s00247-013-2746-6. Epub 2013 Jul 11.

Reference Type BACKGROUND
PMID: 23843130 (View on PubMed)

Parker JM, Weller MW, Feinstein LM, Adams RJ, Main ML, Grayburn PA, Cosgrove DO, Goldberg BA, Darge K, Nihoyannopoulos P, Wilson S, Monaghan M, Piscaglia F, Fowlkes B, Mathias W, Moriyasu F, Chammas MC, Greenbaum L, Feinstein SB. Safety of ultrasound contrast agents in patients with known or suspected cardiac shunts. Am J Cardiol. 2013 Oct 1;112(7):1039-45. doi: 10.1016/j.amjcard.2013.05.042. Epub 2013 Jun 28.

Reference Type BACKGROUND
PMID: 23816393 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-014905

Identifier Type: -

Identifier Source: org_study_id