Actively Recruiting

Age: 18Years - 88Years
All Genders
ID05189262

Extra-Cellular Hemoglobin and Organ Injury in Extended Cardiopulmonary Bypass During Complex Cardiac Surgery

Led by University of Maryland, Baltimore · Updated on 2025-08-19

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Maryland, Baltimore

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how red blood cells break down during cardiopulmonary bypass (CPB) used in complex cardiac surgeries, such as heart valve replacement or coronary artery bypass grafting (CABG). The study focuses on understanding how hemoglobin released into plasma (plasma free hemoglobin, pfH) from damaged red blood cells contributes to organ injury, including the brain, lungs, heart, and kidneys. The research aims to set safe limits for pfH levels during CPB and to develop computer models that predict organ injury risk by measuring pfH and protective proteins that clear it from the blood. Participants in this observational study are patients undergoing complex cardiac surgeries requiring CPB for more than one hour. Researchers will collect blood and urine samples during and after surgery to monitor changes in pfH and protective proteins like haptoglobin, hemopexin, and transferrin. These biological samples will help compare new methods for detecting red blood cell damage with existing laboratory tests. The study does not involve any experimental treatments but focuses on detailed biological specimen collection. During the study, participants will have blood and urine collected at multiple time points during surgery and up to five days after the procedure. Researchers will measure hemolysis (red blood cell breakdown) and kidney injury markers to assess organ damage related to CPB. The study will evaluate changes from baseline at hourly intervals during surgery and daily post-surgery to understand injury dynamics. Participants will be monitored under usual care, and the study aims to improve early detection and prevention strategies for organ injury in cardiac surgery patients.

CONDITIONS

Brief Title

Cardiopulmonary Bypass Induced Red Blood Cell Lysis

Who Can Participate

Age: 18Years - 88Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to UMMC for cardiac procedure
  • Age 18 to 88 years
  • Undergoing cardiopulmonary bypass longer than 1 hour for complex cardiac surgery, heart valve replacement, or CABG surgery
Not Eligible

You will not qualify if you...

  • Pregnant
  • Non English speaking
  • Unable to consent or have a legally authorized representative consent to the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Duration of surgery (approximately 1 to 4 hours)

Participants undergo complex cardiac surgery requiring cardiopulmonary bypass lasting longer than one hour. Blood and urine samples are collected to measure hemolysis and kidney injury during the procedure.

Samples collected during surgery

Post-operative Follow-up

Duration - 5 days post procedure

Participants are monitored for changes in hemolysis and kidney injury through blood and urine sample collections after surgery to assess organ injury and recovery.

Multiple sample collections on hours 2, 24 and days 2 to 5 post procedure

Trial Site Locations

Total: 1 location

1

Center for Blood Oxygen Transport and Hemostasis

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

P

Paul W Buehler, PhD

T

Tobi Rowden, RN

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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