An observational study in Post-Transplant Infections, Post-Transplant Renal Insufficiency and Post-Transplant Pulmonary Complications, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
Objectives:
Eligibility:
Design:
Between 80 and 100 allogeneic stem cell transplants (allo-HSCT) are performed every year at the NIH to treat a variety of malignant and nonmalignant conditions. The current transplant protocols at the NIH focus on research regarding the response of the underlying disease, the development of graft versus host disease (GVHD) as well as the feasibility and safety of a variety of transplant strategies. Many clinically significant complications are considered to be part of the transplant process and are not studied systematically. Even when they are studied, the diverse institute-based protocols differ on the range of complications captured and the amount of information collected on them. This leads to knowledge gaps regarding the incidence and risk factors for complications in the various protocols.
This exploratory natural history study involves a prospective review of the medical records of patients actively enrolled in allo-HSCT protocols at the NIH. The study will focus on infections and a subset of noninfectious complications identified by the transplant community as significant causes of morbidity, mortality and cost. The cost data captured in this study will be the cost consumed by the Clinical Center. This study does not require any sample collection and will consist merely of data collection and optional periodic patient examinations that will be performed in conjunction with those already scheduled by the original transplant protocol. The prospective collection of clinical data and information available in the medical record will allow us to determine the rates of a number of complications in different protocols. At the completion of the study, it is expected the investigators will be able to generate preliminary hypotheses regarding risk factors for infection and noninfectious complications, the impact of complications on transplant costs and the correlation between laboratory immune reconstitution (usually determined by each transplant protocol in a variety of ways and functional immune reconstitution (frequency of infections).
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 100 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
From NIH transplant protocols
Subjects over the age of 2 that are actively enrolled in an allo-HSCT protocol at any NIH institute will be eligible to participate in this study regardless of gender or medical condition. Patients may be consented prior to and up to a week after receiving the stem cells (Day 0 of transplant).
EXCLUSION CRITERIA:
Subjects with any condition that, in the opinion of the investigator, contraindicates participation in the study will be excluded.
Patients receiving allogenic stem cell transplants at the NIH CC
Characterize the infectious and noninfectious complications associated with allo-HSCT, including incidence, clinical course, cost to the Clinical Center and distribution within each NIH intramural transplant protocol
Time frame: Every few years or as requested by the clinical center or investigators.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)