N/A
N=45
Using Ultrasound Elastography to Predict Development of SOS
Sinusoidal Obstruction Syndrome · Complications of Bone Marrow Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02483481 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Sensitivity and Specificity of US for VOD/SOS — 80; 93 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- shear wave ultrasound elastography (Diagnostic_test)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of US for VOD/SOS |
80; 93 | — |
| SECONDARY Severity of SOS |
2 | — |
Summary
Sinusoidal obstruction syndrome (SOS) is a potentially fatal hepatic veno-occlusive disease-affecting children following bone marrow transplantation (BMT). SOS most likely develops secondary to sinusoidal endothelial damage and subsequent obstruction. The disease can be separated into mild, moderate, and severe forms; almost all patients diagnosed with severe SOS will die from this disease. Children with severe SOS suffer from multi-organ failure with signs and symptoms of portal hypertension (ascites, varices, edema), renal and respiratory failure . Although these children may be few and far between, the mere severity of the disease process and awful prognosis factors are valid reasons for more medical attention. SOS is usually diagnosed via clinical criteria and, despite available prophylaxis and treatment, children continue to die from this devastating disease.
Quantitative shear wave ultrasound elastography with acoustic force radiation imaging is an emerging technology that uses ultrasound pressure waves to provide an estimate of tissue stiffness. This technique is promising for pediatric imaging because it is portable, quick to perform, relatively low cost and involves no ionizing radiation. Acoustic force radiation imaging and ultrasound elastography does not have any increased risks over conventional ultrasound imaging.
Eligibility Criteria
Inclusion Criteria
- All patients who are admitted for BMT from the date of study approval until patient accrual is met.
Exclusion Criteria
- BMT patients who do not end up undergoing transplant during that admission. BMT patients who do not receive any abdominal ultrasounds post transplantation BMT patients who do not consent to the study.
Data sourced from ClinicalTrials.gov (NCT02483481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.