An observational study in Stem Cell Transplant Complications, Hyperglycemia and Hypoglycemia, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by University of Colorado, Denver · Observational
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant (HSCT) between 1994 and 2016 to evaluate incidence of malglycemia and the relationship to specific outcomes.
This is a retrospective chart review of patients who underwent a hematopoietic stem cell transplant between 2007 and 2016 to evaluate incidence and risk factors of malglycemia. The review will also aim to characterize relationships between specific outcomes and malglycemia in pediatric HSCT patients.
713 studies on the registry are indexed under Hyperglycemia; 108 are open to participants now.
This study's enrollment of 344 is above the median of 100 across 159 observational studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients who received hematopoietic stem cell transplants with the Bone Marrow Transplant Program at Children's Hospital Colorado from January 1, 2007 to July 31, 2016.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Procedure: Hematopoietic Stem Cell Transplant
Procedure: Hematopoietic Stem Cell Transplant
Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.
Number of patients experiencing malglycemia in primary admission for pediatric HSCT patients
hypoglycemia (BG \< 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL)
Time frame: Transplant Day -14 to +100
Number of patients with versus without malglycemia who experience infection
It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant infections. This outcome will be assessed for differences in incidence based on malglycemia occurence
Time frame: Transplant Day 0 to +100
Determine whether specific exposures are associated with increased occurrence of malglycemia
The occurrence of the outcome, malglycemia, with be assessed for differences in incidence that may occur as a result of age, medication exposures (use of glucocorticoids, asparaginase, total parenteral nutrition (TPN), or calcineurin inhibitors), underlying diagnosis, and transplant type
Time frame: Transplant Day -14 to +100
Survival rate of patients with versus without malglycemia
It is hypothesized that patients who experience malglycemia will have an increased rate of post-transplant mortality. This outcome will be assessed for differences in incidence based on malglycemia occurrence
Time frame: Transplant Day 0 through date of relapse or death
Occurrence of graft-versus-host disease (GVHD) in patients with versus without malglycemia
It is hypothesized that patients who experience malglycemia will have an increased rate of GVHD. This outcome will be assessed for differences in incidence based on malglycemia occurrence
Time frame: Transplant Day 0 through date of relapse or death
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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