Clinical Trial: Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Biomarkers of Endothelial Dysfunction in Pediatric Patients Receiving High Intensity Chemotherapy/Irradiation

Brief 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 Summary: 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.
Sponsor: Indiana University

Current Primary Outcome: SOS proteomic markers [ Time Frame: Until the end of the study evaluation, day 180 ]

Measure for 3 SOS proteomic markers, L-Ficolin, HA, and ST2, as early predictors of SOS incidence through study completion.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: April 24, 2017
Date Started: April 1, 2017
Date Completion: April 30, 2020
Last Updated: April 26, 2017
Last Verified: April 2017