Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05189262
Status:
RECRUITING
Last Update Posted:
2023-11-02
First Post:
2021-11-09
Brief Title:
Cardiopulmonary Bypass Induced Red Blood Cell Lysis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Extra-Cellular Hemoglobin Organ Injury in Extended Cardiopulmonary Bypass
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Studying the dynamics of red blood cell lysis pfH protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety Further results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB
Detailed Description:
Cost estimates for brain lung cardiac and kidney complications following complex cardiac surgeries that require a medical assist device to by-pass the heart and lungs cardiopulmonary bypass CPB is estimated to cost 80 million per individual states in the US over a ten-year period These extra costs represent a significant burden on the healthcare system but could be reduced by understanding how medical assist devices lead to organ injury associated with complex cardiac surgeries The primary goals of this research are to 1 understand how hemoglobin released into plasma pfH from damaged red blood cells that passage through CPB contributes to organ injury 2 Determine the amount of pfH necessary to cause organ injury 3 Determine the concentration changes in protective proteins called haptoglobin hemopexin and transferrin that remove pfH and its degradation products from the circulation 4 Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury By studying the dynamics of red blood cell lysis pfH protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety Further results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB The primary goals of this research are to 1 understand how hemoglobin released into plasma pfH from damaged red blood cells that passage through CPB contributes to organ injury 2 Determine the amount of pfH necessary to cause organ injury 3 Determine the concentration changes in protective proteins called haptoglobin hemopexin and transferrin that remove pfH and its degradation products from the circulation 4 Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury By studying the dynamics of red blood cell lysis pfH protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety Further results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL162120-01 | NIH | None | httpsreporternihgovquickSearch1R01HL162120-01 |