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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03132337
Study type Observational
Source Indiana University
Contact
Status Completed
Phase
Start date April 1, 2017
Completion date January 14, 2021

See also
  Status Clinical Trial Phase
Completed NCT04141735 - Detection of Sinusoidal Obstruction Syndrome With Ultrasound After Allogeneic HSCT
Completed NCT03858530 - Ultrasound Elastography to Predict Development of SOS Phase 4
Recruiting NCT05987124 - Defibrotide Dose-escalation for SOS Post-HSCT Phase 2
Recruiting NCT04313036 - 5-day Defibrotide Treatment for Hepatic SOS/VOD Phase 2
Completed NCT00885950 - Prevention of the Hepatic Sinusoidal Obstruction Syndrome by Means of Anticoagulants N/A
Completed NCT02483481 - Using Ultrasound Elastography to Predict Development of SOS N/A
Recruiting NCT06054451 - Clinical Diagnosis and Pathological Spectrum of Porto-sinusoidal Vascular Disease in India
Completed NCT03426358 - Liver Stiffness Measurement Predicts VOD/SOS Development (ELASTOVOD ITALIAN MULTICENTRIC STUDY) N/A
Not yet recruiting NCT06258525 - SAMe in Prevention of Oxaliplatin-associated Liver Injury Phase 2
Withdrawn NCT03963999 - Validating Ultrasound Biomarkers for Hepatic Sinusoidal Obstruction Syndrome in Pediatric Hematopoietic Cell Transplant Patients Phase 4
Recruiting NCT03865589 - Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome N/A