A Prospective Registry of Pediatric Cellular Therapy Patients at Risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS).

ConditionHematopoietic Cell Transplantation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-26

SponsorDuke University

About this trial

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 criteria

Qualifiers

Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.

Recipients of autologous and allogeneic HSCT.

Any preparative regimen.

Disqualifiers

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.

Trial design

Treatments tested in this trial

Biorepository Trial

Treatment groups

500 Participants

are divided into 1 treatment group

Sponsors and collaborators

Duke University

Lead sponsor

Source ClinicalTrials.gov