Validating Ultrasound Biomarkers for Hepatic Sinusoidal Obstruction Syndrome in Pediatric Hematopoietic Cell Transplant Patients
Withdrawn before enrolling · Phase 4
Conditions studied: Sinusoidal Obstruction Syndrome, Veno Occlusive Disease, Hepatic, Bone Marrow Transplant Complications, Stem Cell Transplant Complications
In brief
Hepatic veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) is a potentially fatal complication of hematopoietic cell transplant (HCT). Historically VOD/SOS has been clinically diagnosed using the modified Seattle criteria or the Baltimore criteria. The modified Seattle Criteria define VOD/SOS diagnosis is made when two of the following three criteria are present in a patient within 21 days of transplantation: hyperbilirubinemia (total serum bilirubin \> 2 mg/dL), hepatomegaly or right upper quadrant liver pain, and weight gain (\> 2% of baseline) or ascites. Other conditions like graft versus host disease, sepsis syndrome (fever and hypotension), cardiac failure, or tumor infiltration) have to be excluded. This definition was from a well-designed retrospective cohort study on 255 adult and pediatric HCT patients in which the VOD/SOS incidence was 21%. McDonald et al followed up this work with a prospective cohort study of 355 patients noting an incidence of VOD/SOS of 54%. These seminal studies have had a major impact on the field by defining clinical diagnostic criteria. An alternative diagnostic criteria (Baltimore criteria) was proposed by Jones et al as a part of a well-designed retrospective review of 235 HCT patients finding a VOD/SOS incidence of 22%. Jones defined VOD/SOS as the presence of hyperbilirubinemia (total serum bilirubin \> 2 mg/dL) along with at least 2 of 3 other findings: hepatomegaly, ascites, and weight gain (\> 5% of baseline).
Key facts
- Study ID
- NCT03963999
- Run by
- Children's Mercy Hospital Kansas City
- People needed
- 0
- Starts
- 2020-04-01
- Expected to finish
- 2025-04-01
- Last updated by the study team
- 2020-01-13
Who can join
Age: 0 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HCT patient under 25 years of age with
- myeloablative conditioning,
- prior liver damage or
- other high risk factor:
- Neuroblastoma,
- HLH,
- Osteopetrosis,
- Thalassemia,
- Treatment with inotuzumab or gemtuzumab within 3 months prior to HCT admission,
- Hepatic iron overload,
- Steatohepatitis,
- Active inflammatory or infection hepatitis or
- Any other condition which puts the patient at a higher risk of developing VOD).
You may not qualify if…
- Any patient who has contraindication to any of the ultrasound procedures (e.g. unable to hold still).
Where it is running
- Children's Mercy Hospital — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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