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NCT Number: NCT05189262

Cardiopulmonary Bypass Induced Red Blood Cell Lysis

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.

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Key information

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and Urine Collection

Other

No intervention - Biological specimen collection

Primary outcomes

  1. Hemolysis

    Time frame: Change from baseline at hour 1 during procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron

  2. Hemolysis

    Time frame: Change from baseline at hour 2 during procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron

  3. Hemolysis

    Time frame: Change from baseline at hour 3 during procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron

  4. Hemolysis

    Time frame: Change from baseline at hour 4 during procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.

    Change from Baseline at Hour 1 during procedure

  5. Hemolysis

    Time frame: Change from baseline at hour 4 post procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.

    Change from Baseline at Hour 1 during procedure

  6. Hemolysis

    Time frame: Change from baseline at hour 2 post procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.

    Change from Baseline at Hour 1 during procedure

  7. Hemolysis

    Time frame: Change from baseline at hour 24 post procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.

    Change from Baseline at Hour 1 during procedure

  8. Hemolysis

    Time frame: Change from baseline on day 2 post procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.

    Change from Baseline at Hour 1 during procedure

  9. Hemolysis

    Time frame: Change from baseline on day 3 post procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.

    Change from Baseline at Hour 1 during procedure

  10. Hemolysis

    Time frame: Change from baseline on day 4 post procedure

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.

    Change from Baseline at Hour 1 during procedure

  11. Hemolysis

    Time frame: 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 outcomes

  1. Kidney injury

    Time frame: Change from baseline at hour 1 during procedure

    Change in creatinine, KIM-1 and NGAL

  2. Kidney injury

    Time frame: Change from baseline at hour 2 during procedure

    Change in creatinine, KIM-1 and NGAL

  3. Kidney injury

    Time frame: Change from baseline at hour 3 during procedure

    Change in creatinine, KIM-1 and NGAL

  4. Kidney injury

    Time frame: Change from baseline at hour 4 during procedure

    Change in creatinine, KIM-1 and NGAL

  5. Kidney injury

    Time frame: Change from baseline at hour 2 post procedure

    Change in creatinine, KIM-1 and NGAL

  6. Kidney injury

    Time frame: Change from baseline at hour 24 post procedure

    Change in creatinine, KIM-1 and NGAL

  7. Kidney injury

    Time frame: Change from baseline at 2 days post procedure

    Change in creatinine, KIM-1 and NGAL

  8. Kidney injury

    Time frame: Change from baseline at 3 days post procedure

    Change in creatinine, KIM-1 and NGAL

  9. Kidney injury

    Time frame: Change from baseline at 4 days post procedure

    Change in creatinine, KIM-1 and NGAL

  10. Kidney injury

    Time frame: Change from baseline at 5 days post procedure

    Change in creatinine, KIM-1 and NGAL

Other outcomes

  1. Blood cell function

    Time frame: Change from baseline at hour 1 during procedure

    CBC and red blood cell deformability

  2. Blood cell function

    Time frame: Change from baseline at hour 2 during procedure

    CBC and red blood cell deformability

  3. Blood cell function

    Time frame: Change from baseline at hour 3 during procedure

    CBC and red blood cell deformability

  4. Blood cell function

    Time frame: Change from baseline at hour 4 during procedure

    CBC and red blood cell deformability

  5. Blood cell function

    Time frame: Change from baseline at hour 2 post procedure

    CBC and red blood cell deformability

  6. Blood cell function

    Time frame: Change from baseline at hour 24 post procedure

    CBC and red blood cell deformability

  7. Blood cell function

    Time frame: Change from baseline at day 2 post procedure

    CBC and red blood cell deformability

  8. Blood cell function

    Time frame: Change from baseline at day 3 post procedure

    CBC and red blood cell deformability

  9. Blood cell function

    Time frame: Change from baseline at day 4 post procedure

    CBC and red blood cell deformability

  10. Blood cell function

    Time frame: Change from baseline at day 5 post procedure

    CBC and red blood cell deformability

  11. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at hour 1 during procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  12. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at hour 2 during procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  13. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at hour 3 during procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  14. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at hour 4 during procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  15. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at hour 2 post procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  16. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at hour 24 post procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  17. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at day 2 post procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  18. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at day 3 post procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  19. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at day 4 post procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

  20. Outcome Hemoglobin Clearance

    Time frame: Change from baseline at day 5 post procedure

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

Study contacts

Contact information is provided by the study sponsor or research team.

Paul W Buehler, PhD

CONTACT

[email protected]

14107065171

Tobi Rowden, RN

CONTACT

[email protected]

4107064061

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Extra-Cellular Hemoglobin, Organ Injury in Extended Cardiopulmonary Bypass

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2022
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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