Ultrasound Elastography to Predict Development of SOS
|ClinicalTrials.gov Identifier: NCT03858530|
Recruitment Status : Active, not recruiting
First Posted : February 28, 2019
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Transplant Complications Sinusoidal Obstruction Syndrome Veno-occlusive Disease Stem Cell Transplant Complications||Diagnostic Test: Ultrasound Examination||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using Ultrasound Elastography to Predict Development of Sinusoidal Obstruction Syndrome|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: All Patients Enrolled
All patients will undergo limited abdominal US with Doppler and SWE once a week upon admission for conditioning until the patient day +30 BMT or discharge, whichever comes first. Additional ultrasounds will also be performed if SOS is suspected.
Diagnostic Test: Ultrasound Examination
Grayscale ultrasound, Doppler ultrasound, ultrasound elastography with or without ultrasound intravenous contrast will be performed.
- SWE Accuracy for Diagnosing SOS [ Time Frame: 100 days post transplant ]Determining accuracy of shear wave ultrasound elastography (SWE) for diagnosis of sinusoidal obstruction syndrome (SOS) compared to diagnosis and severity grading using the European Bone Marrow Consoritium (EBMT) clinical criteria.
- Evaluate SWE Accuracy for Severity Grading [ Time Frame: 100 days post transplant ]Evaluate the accuracy of SWE for grading severity of SOS severity compared to severity grading according EBMT clinical criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858530
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shewin Chan, MD, PhD||Children's Mercy Hospital Kansas City|