Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
IRB approval 1/6/2025 to close to accrual with present enrollment. Project completed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Le Bonheur Children's Hospital | OTHER |
| University of Tennessee | OTHER |
| Baylor College of Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Primary Objectives:
Secondary Objectives
The study will require a minimum of 1 blood draw before transplant and 6 blood draws throughout the first 100 days following transplant. If participants are admitted to the intensive care unit or are diagnosed with specific complications additional blood draws will be done. Peripheral arterial tonometry (PAT) testing will occur 1-2 times during the first 100 days in several older patients who can tolerate the procedure by sitting still for the duration of the testing period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline levels of circulating biomarkers | Descriptive statistics (mean, median, standard deviation) will be used. | Baseline (before preparative transplant regimen starts) and Day 0 (on day of transplant, before therapy takes place) |
| Baseline vascular reactivity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants who meet the Eligibility Criteria
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Saad Ghafoor, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Descriptive statistics (mean, median, standard deviation) will be used. |
| Baseline (before preparative transplant regimen starts) and Day 0 (on day of transplant, before therapy takes place) |
| Baseline clot structure | Descriptive statistics (mean, median, standard deviation) will be used. | Baseline (before preparative transplant regimen starts) and Day 0 (on day of transplant, before therapy takes place) |
| Difference in circulating biomarkers | We will compare the levels of circulating biomarkers of patients that experience critical illness (defined by admission to the pediatric intensive care unit at St. Jude for reasons other than observation after procedure) and the patients that do not ever experience critical illness by using the linear mixed-effect model (LMM). Blood draws will be done at baseline, Day 0, and after transplant: days 1, 7, 14, 21, 28, 100 (plus or minus 3 days). Those with Endotheliopathy diagnosis anytime during the 100 days of HCT following cellular transfusion, and are admitted to ICU, will have additional blood draws: At the time of Endotheliopathy diagnosis (plus or minus 3 days), at the time of ICU admission (plus or minus 3 days), 72 hours after ICU admission (plus or minus 3 days), and every 7 days if remains admitted to the intensive care unit for longer than 72 hours (plus or minus 3 days) up to 100 days post ICU submission. | From Baseline blood draws up to 100 days post ICU admission |
| Difference in clot structure | We will compare the clot structure of patients that experience critical illness (defined by admission to the pediatric intensive care unit at St. Jude for reasons other than observation after procedure) and the patients that do not ever experience critical illness by using the linear mixed-effect model (LMM). Blood draws will be done at baseline, Day 0, and after transplant: days 1, 7, 14, 21, 28, 100 (plus or minus 3 days). Those with Endotheliopathy diagnosis anytime during the 100 days of HCT following cellular transfusion, and are admitted to ICU, will have additional blood draws: At the time of Endotheliopathy diagnosis (plus or minus 3 days), at the time of ICU admission (plus or minus 3 days), 72 hours after ICU admission (plus or minus 3 days), and every 7 days if remains admitted to the intensive care unit for longer than 72 hours (plus or minus 3 days) up to 100 days post ICU submission. | From Baseline blood draws up to 100 days post ICU admission |
| Difference in vascular reactivity | We will compare the vascular reactivity of patients that experience critical illness (defined by admission to the pediatric intensive care unit at St. Jude for reasons other than observation after procedure) and the patients that do not ever experience critical illness by using the linear mixed-effect model (LMM). Blood draws will be done at baseline, Day 0, and after transplant: days 1, 7, 14, 21, 28, 100 (plus or minus 3 days). Those with Endotheliopathy diagnosis anytime during the 100 days of HCT following cellular transfusion, and are admitted to ICU, will have additional blood draws: At the time of Endotheliopathy diagnosis (plus or minus 3 days), at the time of ICU admission (plus or minus 3 days), 72 hours after ICU admission (plus or minus 3 days), and every 7 days if remains admitted to the intensive care unit for longer than 72 hours (plus or minus 3 days) up to 100 days post ICU submission. | From Baseline blood draws up to 100 days post ICU admission |
| Time to development of any complications or critical illness | Will be assessed by the Kaplan-Meier method | Up to 100 days after transplant (plus or minus 3 days) |