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Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

NCT03865589 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-01-08

No results posted yet for this study

Summary

To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obstruction syndrome (SOS), mild to moderate SOS, and severe to very severe SOS. Secondarily, the investigators would also like to quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria (Modified Seattle, Baltimore, EBMT consortium).

Conditions

  • Bone Marrow Transplant Complications
  • Sinusoidal Obstruction Syndrome
  • Veno Occlusive Disease, Hepatic
  • Stem Cell Transplant Complications

Interventions

DIAGNOSTIC_TEST

Ultrasound Elastography

Ultrasound shear wave elastography

Sponsors & Collaborators

Principal Investigators

  • Sherwin S Chan, MD, PhD · Children's Mercy Hospital Kansas City

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865589 on ClinicalTrials.gov