Trials / Completed
CompletedNCT03132337
Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study
Biomarkers of Endothelial Dysfunction in Pediatric Patients Receiving High Intensity Chemotherapy/Irradiation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- Indiana University · Academic / Other
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this is to learn more about stem cell transplant and complications that some people have after their transplants, in particular sinusoidal obstruction syndrome (SOS), also called veno-occlusive disease of the liver.
Detailed description
This is a multicenter, prospective, observational trial. We will measure biomarkers and determine thresholds that will predict increased risk for SOS in pediatric patients receiving HCT or high intensity chemotherapy/irradiation with the future goal of a randomized, interventional, open-label, multicenter trial that will test the preemptive use of defibrotide for prevention of SOS in an enriched high-risk population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Serial Blood Draws | Day 0 and Day 3 blood draw for SOS biomarkers. If subject develops SOS blood draw prior to dose of Defibrotide, Day 14 after Defibrotide and Day 21 after Defibrotide. |
Timeline
- Start date
- 2017-04-01
- Primary completion
- 2021-01-14
- Completion
- 2021-01-14
- First posted
- 2017-04-27
- Last updated
- 2023-12-19
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03132337. Inclusion in this directory is not an endorsement.