Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT03472768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2018-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Newborns and children with life-threatening heart and lung failure may require support with ECMO (extracorporeal membrane oxygenation). With ECMO, oxygen and carbon dioxide are exchanged and circulated throughout the body even if the heart is unable to do so. Unfortunately, ECMO can cause breakdown of the red blood cells (known as hemolysis). For unclear reasons, newborns are at particularly high risk of hemolysis while being supported by ECMO. The amount of hemolysis is measured with concentrations of a breakdown product from red blood cells known as free hemoglobin. One possible reason for high free hemoglobin levels in newborns on ECMO could be related to another blood protein called haptoglobin. Haptoglobin is known to help in clearing free hemoglobin through the kidneys into the urine. However, haptoglobin levels in newborns can be very low and increases slowly during the first few months of life. Free hemoglobin may be inappropriately high in newborns supported by ECMO because of low levels of haptoglobin. The purpose of this study is to characterize haptoglobin, free hemoglobin, and hemolysis in newborns and children supported by ECMO and compare those values to age-matched newborns and children not on ECMO.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: