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
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.
Description
Primary: * To evaluate the proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who develop endotheliopathies (SOS, TMA, DAH and IPS) and/or MODS within 100 days of such therapies. * To evaluate the proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who experience abnormal levels of circulating angiogenic, vascular permeability and inflammatory factors within 100 days post HCT-CT in the setting of endotheliopathies. Secondary/Exploratory Objective(s): * To determine the impact of endotheliopathies in the HCT setting on the overall surv…
Eligibility
- Age range
- 0–26 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT. * Recipients of autologous and allogeneic HSCT. * Any preparative regimen. Exclusion Criteria: * 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.
Interventions
- OtherBiorepository Trial
participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points.
Locations (3)
- Mayo ClinicRochester, Minnesota
- Duke UniversityDurham, North Carolina
- MD Anderson Cancer CenterHouston, Texas