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NCT03963999
Validating Ultrasound Biomarkers for Hepatic Sinusoidal Obstruction Syndrome in Pediatric Hematopoietic Cell Transplant Patients
Phase 4 trial testing Ultrasound Elastography in Sinusoidal Obstruction Syndrome. Withdrawn.
30 April 2024
Quick facts
| Lead sponsor | Children's Mercy Hospital Kansas City |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Start date | 1 April 2020 |
| Primary completion | 30 April 2024 |
| Estimated completion | 1 April 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ultrasound Elastography
- Contrast Enhanced Ultrasound (CEUS) — full drug profile →
Conditions studied
- Sinusoidal Obstruction Syndrome — all drugs for Sinusoidal Obstruction Syndrome →
- Veno Occlusive Disease, Hepatic — all drugs for Veno Occlusive Disease, Hepatic →
- Bone Marrow Transplant Complications — all drugs for Bone Marrow Transplant Complications →
- Stem Cell Transplant Complications — all drugs for Stem Cell Transplant Complications →
Sponsor
Children's Mercy Hospital Kansas City
Who can join
Adults 1 Month to 25, any sex, with Sinusoidal Obstruction Syndrome or Veno Occlusive Disease, Hepatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03963999
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Related trials
Other trials of Ultrasound Elastography
Trials testing the same drug.
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- NCT04130048 — Thrombus Elastography in Venous Thrombo-Embolism. · unknown
- NCT03865589 — Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome · NA · active not recruiting
Other recruiting trials for Sinusoidal Obstruction Syndrome
Currently open trials in the same condition.
- NCT05987124 — Defibrotide Dose-escalation for SOS Post-HSCT · Phase 2 · recruiting
- NCT03865589 — Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome · NA · active not recruiting
Other Children's Mercy Hospital Kansas City trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03963999 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Mercy Hospital Kansas City
- Last refreshed: 13 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03963999.
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