NCT05594251|Terminated
Study Stopped
IRB approval 1/6/2025 to close to accrual with present enrollment. Project completed.
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IRB approval 1/6/2025 to close to accrual with present enrollment. Project completed.
Sponsor study identifier
observational
32
1 country
1
Study Start
November 28, 2022
Actual (reported)Primary Completion
May 5, 2024
Actual (reported)Study Completion
May 5, 2024
Actual (reported)The goal of this research study is to learn more about possible risk factors that might be associated with side effects from stem cell transplants in people between the ages of 0 to 26 years old. Specifically, this study is looking at complications that arise from injury to the endothelium, a small layer of cells lining the blood vessels and heart. These complications can affect the heart, lungs, liver, kidneys and intestines and increase risk of severe illness needing care in the intensive care unit.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 5, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2022
Actual (reported)October 26, 2022
Actual (reported)November 28, 2022
Actual (reported)May 5, 2024
Actual (reported)May 5, 2024
Actual (reported)Proportion of pediatric patients undergoing Hematopoietic cell transplantation (HCT) who develop critical illness
The proportion of pediatric patients undergoing HCT who develop critical illness (defined by admission to the pediatric intensive care unit at St. Jude for reasons other than observation after procedure) will be estimated using one-sample binomial estimates and various confidence intervals.
Up to 100 days after transplant (plus or minus 3 days)
Proportion of pediatric patients undergoing HCT who experience development of endothelial-related organ dysfunction syndromes
The proportion will be estimated using one-sample binomial estimates and various confidence intervals.
Up to 100 days after transplant (plus or minus 3 days)
Baseline levels of circulating biomarkers
Baseline (before preparative transplant regimen starts) and Day 0 (on day of transplant, before therapy takes place)
Baseline vascular reactivity
Baseline (before preparative transplant regimen starts) and Day 0 (on day of transplant, before therapy takes place)
Baseline clot structure
Baseline (before preparative transplant regimen starts) and Day 0 (on day of transplant, before therapy takes place)
Difference in circulating biomarkers
From Baseline blood draws up to 100 days post ICU admission
Difference in clot structure
From Baseline blood draws up to 100 days post ICU admission
Participants who meet the Eligibility Criteria
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Saad Ghafoor, MD
St. Jude Children's Research Hospital
32 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2022
First Posted
October 26, 2022
Study Start
November 28, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 5, 2024
Actual (reported)Study Completion
May 5, 2024
Actual (reported)Last Updated
January 24, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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