Cardiopulmonary BypassNCT05189262
Cardiopulmonary Bypass Induced Red Blood Cell Lysis
An observational study of Cardiopulmonary Bypass and Cardiac Surgery, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Cardiopulmonary Bypass, Cardiac Surgery, Kidney Injury, Acute
- What is being tested?
- Blood and urine collection
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant
- Non English speaking
- Unable to consent or have Legally Authorized Representative (LAR) assent to study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Blood Oxygen Transport and Hemostasis
Baltimore, Maryland, 21201
About this study
Official title: Extra-Cellular Hemoglobin, Organ Injury in Extended Cardiopulmonary Bypass
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.
- Being tested
- Blood and urine collection
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine collectionOther
No intervention - Biological specimen collection
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Sugery Patients Requiring Cardiopulmonary >1hour | Patients admitted for a complex cardiac surgery, heart valve replacement and/or CABG surgery requiring CPB >1hour Receives: Other: Blood and urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Measured: Change from baseline at hour 1 during procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Measured: Change from baseline at hour 2 during procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Measured: Change from baseline at hour 3 during procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline at hour 4 during procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline at hour 4 post procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline at hour 2 post procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline at hour 24 post procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline on day 2 post procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline on day 3 post procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline on day 4 post procedure
Hemolysis
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.
Change from Baseline at Hour 1 during procedure
Measured: Change from baseline on day 5 post procedure
Secondary outcomes (10)
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at hour 1 during procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at hour 2 during procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at hour 3 during procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at hour 4 during procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at hour 2 post procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at hour 24 post procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at 2 days post procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at 3 days post procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at 4 days post procedure
Kidney injury
Change in creatinine, KIM-1 and NGAL
Measured: Change from baseline at 5 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start22 Mar 2022
- Primary completionDec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Paul Buehler, University of Maryland, Baltimore
- Investigators
- Paul Buehler, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189262
- Sponsor's protocol ID
- HP-00094849
- Other IDs
- 1R01HL162120-01
- Status last verified
- Aug 2026
- First submitted
- 9 Nov 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data may be used in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra-Cellular Hemoglobin, Organ Injury in Extended Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05189262
- Acronym / sponsor ID
- HP-00094849
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Sugery Patients Requiring Cardiopulmonary >1hour | – | Other: Blood and urine collectionPatients admitted for a complex cardiac surgery, heart valve replacement and/or CABG surgery requiring CPB >1hour |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant
- Non English speaking
- Unable to consent or have Legally Authorized Representative (LAR) assent to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine collectionNo intervention - Biological specimen collection | Other | Cardiac Sugery Patients Requiring Cardiopulmonary >1hour |
Primary outcome
Hemolysis
Time frame: Change from baseline at hour 1 during procedure
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Hemolysis
Time frame: Change from baseline at hour 2 during procedure
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
Hemolysis
Time frame: Change from baseline at hour 3 during procedure
Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron
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
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
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
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
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
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
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
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
10 secondary outcomes
Kidney injury
Time frame: Change from baseline at hour 1 during procedure
Kidney injury
Time frame: Change from baseline at hour 2 during procedure
Kidney injury
Time frame: Change from baseline at hour 3 during procedure
Kidney injury
Time frame: Change from baseline at hour 4 during procedure
Kidney injury
Time frame: Change from baseline at hour 2 post procedure
Kidney injury
Time frame: Change from baseline at hour 24 post procedure
Kidney injury
Time frame: Change from baseline at 2 days post procedure
Kidney injury
Time frame: Change from baseline at 3 days post procedure
Kidney injury
Time frame: Change from baseline at 4 days post procedure
Kidney injury
Time frame: Change from baseline at 5 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided. Deidentified data may be used in a publication
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Recruiting
Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
Cardiopulmonary Bypass, Obese Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Buehler, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass and Cardiac Surgery, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemolysis (time frame: Change from baseline at hour 1 during procedure). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.