Cardiopulmonary Bypass Induced Red Blood Cell Lysis

Recruiting

• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Kidney Injury, Acute
• Interventions: Other: Blood and urine collection

• Registration Number: NCT05189262
• Lead Sponsor: University of Maryland, Baltimore

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 Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-12
• Study Start: 2022-03-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Admitted to UMMC for cardiac procedure
• Age: >/=18 y.o TO 88 y.o.
• Undergoing CPB >1hr for the following surgeries (a) complex cardiac surgery (b) heart valve replacement surgery OR (c) CABG surgery.

Exclusion Criteria

• Pregnant
• Non English speaking
• Unable to consent or have Legally Authorized Representative (LAR) assent to study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Sugery Patients Requiring Cardiopulmonary >1hour	Blood and urine collection	Patients admitted for a complex cardiac surgery, heart valve replacement and/or CABG surgery requiring CPB \>1hour

Primary Outcome Measures

Name	Time	Method
Hemolysis	Change from baseline on day 5 post procedure	Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.; Change from Baseline at Hour 1 during procedure

Secondary Outcome Measures

Name	Time	Method
Kidney injury	Change from baseline at 5 days post procedure	Change in creatinine, KIM-1 and NGAL

Trial Locations

Locations (1)

Center for Blood Oxygen Transport and Hemostasis; 🇺🇸 Baltimore, Maryland, United States