Cardiopulmonary Bypass Induced Red Blood Cell Lysis

NCT05189262 | Recruiting DMC

• 2 other identifiers: HP-000948491R01HL162120-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiopulmonary Bypass; Cardiac Surgery; Kidney Injury, Acute

Outcome Measures

Primary Outcomes (11)

• Hemolysis

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

  Change from baseline at hour 1 during procedure

• Hemolysis

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

  Change from baseline at hour 2 during procedure

• Hemolysis

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

  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

  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

  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

  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

  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

  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

  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

  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

  Change from baseline on day 5 post procedure

Secondary Outcomes (10)

• Kidney injury

  Change from baseline at hour 1 during procedure

• Kidney injury

  Change from baseline at hour 2 during procedure

• Kidney injury

  Change from baseline at hour 3 during procedure

• Kidney injury

  Change from baseline at hour 4 during procedure

• Kidney injury

  Change from baseline at hour 2 post procedure

Other Outcomes (20)

• Blood cell function

  Change from baseline at hour 1 during procedure

• Blood cell function

  Change from baseline at hour 2 during procedure

• Blood cell function

  Change from baseline at hour 3 during procedure

Study Arms (1)

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

Blood and urine collection OTHER

No intervention - Biological specimen collection

Cardiac Sugery Patients Requiring Cardiopulmonary >1hour

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Center for Blood Oxygen Transport and Hemostasis

Baltimore, Maryland, 21201, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Red blood cells, plasma and urine

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul Buehler, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul W Buehler, PhD

CONTACT

14107065171; pbuehler@som.umaryland.edu

Tobi Rowden, RN

CONTACT

4107064061; trowden@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Faculty

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: January 12, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)