A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).
Prospective Multi Center Study of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS)
Duke University
500 participants
Nov 19, 2019
OBSERVATIONAL
Conditions
Summary
This is a prospective international multi-center registry and biorepository trial of children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the HCT setting as a contributor of significant morbidity and mortality.
Eligibility
Inclusion Criteria3
- Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.
- Recipients of autologous and allogeneic HSCT.
- Any preparative regimen.
Exclusion Criteria2
- Any patient who does not consent/assent to participation.
- Any patient for whom 5 mL blood sample(s) drawn at specified intervals would pose any more than minimal risk, as defined by institutional guidelines and at discretion of treating physician will be ineligible for biorepository banking.
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Interventions
participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05090345