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Observational Study on Cardiopulmonary Bypass and Red Blood Cell Lysis

This study is looking at how using a heart-lung machine (cardiopulmonary bypass, or CPB) during heart surgery affects your red blood cells. Specifically, researchers want to understand how red blood cells can break down (hemolysis) during CPB and release hemoglobin into your blood (pfH). They will collect blood and urine samples to measure pfH and protective proteins. The goal is to find safe levels of pfH and understand how it might lead to organ injury, especially in the kidneys. This information could help develop better ways to protect patients during heart surgery. You may be able to join if you are between 18 and 88 years old, are having certain complex heart surgeries requiring CPB, and can provide consent. The study's current recruitment status is unclear.

Study design
This is an observational study planning to include 150 participants. It is not testing a new treatment but rather observing how the body responds during surgery.
What's involved
You would provide blood and urine samples during your cardiac procedure. The specific number of samples or duration of collection is not detailed.
Compensation
Not stated in the trial record.
Follow-up
Hemolysis is measured at 1, 2, and 3 hours during the procedure. No further follow-up after the procedure is specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05189262

Cardiopulmonary Bypass Induced Red Blood Cell Lysis

Active, Not Recruiting
Not specifiedAges 18–88Observational
University of Maryland, Baltimore
~111 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Blood and urine collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hemolysis
Measured over Change from baseline at hour 1 during procedure
+10 more outcomes measured

Conditions

Cardiopulmonary Bypass
Cardiac Surgery
Kidney Injury, Acute

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Paul Buehler, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • HemolysisChange from baseline at hour 1 during procedure

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

  • HemolysisChange from baseline at hour 2 during procedure

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

  • HemolysisChange from baseline at hour 3 during procedure

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

  • HemolysisChange 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

  • HemolysisChange 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

  • HemolysisChange 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

  • HemolysisChange 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

  • HemolysisChange 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

  • HemolysisChange 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

  • HemolysisChange 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

  • HemolysisChange 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