Understanding red blood cell damage during heart surgery
Extra-Cellular Hemoglobin, Organ Injury in Extended Cardiopulmonary Bypass
This study is trying to understand how damage to red blood cells during heart surgery affects organ health, so doctors can find better ways to protect patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05189262 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how red blood cell lysis and the release of hemoglobin into plasma (pfH) during cardiopulmonary bypass (CPB) contribute to organ injury in patients undergoing complex cardiac surgeries. It aims to determine safe levels of pfH and the role of protective proteins in mitigating damage. By collecting blood and urine samples, the study will develop a computer model to predict organ injury risk based on pfH and protein levels. The findings could lead to improved therapeutic strategies for early detection and management of organ injury associated with CPB.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 88 who are admitted for complex cardiac procedures requiring cardiopulmonary bypass.
Not a fit: Patients who are pregnant, non-English speaking, or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and prevention of organ injury in patients undergoing cardiac surgery.
How similar studies have performed: While the approach of studying pfH and organ injury is innovative, similar studies have shown promise in understanding red blood cell damage during cardiac procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Center for Blood Oxygen Transport and Hemostasis — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Paul Buehler, PhD — University of Maryland
- Study coordinator: Paul W Buehler, PhD
- Email: pbuehler@som.umaryland.edu
- Phone: 14107065171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.