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Active, not recruitingNCT05189262Updated Aug 21, 2026

Cardiopulmonary Bypass Induced Red Blood Cell Lysis

An observational study in Cardiopulmonary Bypass, Cardiac Surgery and Kidney Injury, Acute, sponsored by University of Maryland, Baltimore. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by University of Maryland, Baltimore · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Ages
18 Years to 88 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiopulmonary Bypass
  • Cardiac Surgery
  • Kidney Injury, Acute

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03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 111 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 88 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Research Participants will include approximately 90 adult (>/=18 years of age to 75 years of age) medium to high risk patients. Both Male and female subjects who are undergoing complex cardiac surgery requiring, heart valve replacement, or CABG surgery requiring cardiopulmonary bypass >1hr will be eligible for enrollment at the University of Maryland Medical Center (UMMC) in Baltimore, MD. This study is a prospective observational investigation.

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

Exclusion Criteria:

  • Pregnant
  • Non English speaking
  • Unable to consent or have Legally Authorized Representative (LAR) assent to study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cardiac Sugery Patients Requiring Cardiopulmonary >1hour

    Patients admitted for a complex cardiac surgery, heart valve replacement and/or CABG surgery requiring CPB \>1hour

    Other: Blood and urine collection

Interventions

  • OtherBlood and urine collection

    No intervention - Biological specimen collection

06

What researchers measure

Primary outcomes

  1. Hemolysis

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

    Time frame: Change from baseline at hour 1 during procedure

  2. Hemolysis

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

    Time frame: Change from baseline at hour 2 during procedure

  3. Hemolysis

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

    Time frame: Change from baseline at hour 3 during procedure

  4. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline at hour 4 during procedure

  5. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline at hour 4 post procedure

  6. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline at hour 2 post procedure

  7. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline at hour 24 post procedure

  8. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline on day 2 post procedure

  9. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline on day 3 post procedure

  10. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline on day 4 post procedure

  11. Hemolysis

    Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc. Change from Baseline at Hour 1 during procedure

    Time frame: Change from baseline on day 5 post procedure

Secondary outcomes

  1. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at hour 1 during procedure

  2. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at hour 2 during procedure

  3. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at hour 3 during procedure

  4. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at hour 4 during procedure

  5. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at hour 2 post procedure

  6. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at hour 24 post procedure

  7. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at 2 days post procedure

  8. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at 3 days post procedure

  9. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at 4 days post procedure

  10. Kidney injury

    Change in creatinine, KIM-1 and NGAL

    Time frame: Change from baseline at 5 days post procedure

Other outcomes

  1. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at hour 1 during procedure

  2. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at hour 2 during procedure

  3. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at hour 3 during procedure

  4. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at hour 4 during procedure

  5. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at hour 2 post procedure

  6. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at hour 24 post procedure

  7. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at day 2 post procedure

  8. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at day 3 post procedure

  9. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at day 4 post procedure

  10. Blood cell function

    CBC and red blood cell deformability

    Time frame: Change from baseline at day 5 post procedure

  11. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at hour 1 during procedure

  12. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at hour 2 during procedure

  13. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at hour 3 during procedure

  14. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at hour 4 during procedure

  15. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at hour 2 post procedure

  16. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at hour 24 post procedure

  17. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at day 2 post procedure

  18. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at day 3 post procedure

  19. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at day 4 post procedure

  20. Outcome Hemoglobin Clearance

    Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations

    Time frame: Change from baseline at day 5 post procedure

07

Study locations

1 site
  • Center for Blood Oxygen Transport and Hemostasis
    Baltimore, Maryland 21201, United States
08

References and documents

Individual participant data

Plan to share: Undecided — Deidentified data may be used in a publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05189262
Lead sponsor
University of Maryland, Baltimore
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Paul Buehler (Research Faculty, University of Maryland, Baltimore) — Principal investigator
First posted
Jan 12, 2022
Start date
Mar 22, 2022
Primary completion
Dec 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Paul Buehler, PhD
principal investigator · University of Maryland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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