Non-Encapsulated Heme Levels in Adult Cardiac Surgery

NCT04043507 | Terminated DMC

• 2 other identifiers: 300002894UAB
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Non-encapsulated (free) heme, a breakdown component of hemoglobin, is associated with oxidative stress and inflammation with consequent cellular and tissue injury (Ryter \& Tyrrell, 2000) (D T G Wagener, et al., 2001). Cardiopulmonary bypass is known to cause trauma to cellular components of the blood, to trigger an inflammatory response, and alter the rheology of the circulation. Prior research has demonstrated an increase in levels of free heme with cardiopulmonary bypass (Wetz, Richardt, Schotola, Bauer, \& Bräuer, 2017) (Kubota, Egi, \& Mizobuchi, 2017). The stress response to cardiac surgery and utilization of blood salvage techniques independent of cardiopulmonary bypass may affect plasma free heme levels as well as regulation of heme metabolism pathways. It is unclear whether and to what degree plasma levels of free heme may vary at discreet time points in the perioperative period during cardiac surgery involving both cardiopulmonary bypass and "off-pump" techniques. This is an observational, prospective cohort study in which we will assess for red blood cell trauma, free heme levels, and biomarkers for acute kidney injury at various time points throughout cardiac surgery. Urine and arterial blood samples will be collected at our routine, standard of care time points pre-, intra-, and post-operatively and in addition to the standard clinical tests that will be performed (arterial blood gas analysis and activated clotting time) several additional serum biomarkers will be analyzed. Clinical correlation will be performed with levels. Sub-analysis will be performed on the basis of off vs. on pump CABG cases and also in patient that do/not develop AKI post-operatively.

Conditions

Adult Cardiac Surgery

Keywords

Heme; Cardiac; Surgery

Outcome Measures

Primary Outcomes (1)

• Red Blood Cell Stability

  We will be looking at the level of red blood cell damage that occurs during cardiac surgery. This will be examined by measuring the level of non-encapsulated heme levels in enrolled patients. The concept is that the body can respond to a certain amount of heme, which is a component of hemoglobin that rises as red blood cells are damaged in vivo.

  This outcome will be measured by analyzing the difference in heme levels after surgery to the levels of heme before the surgery. Generally, this time frame would be no greater than from one hour prior to induction to one hour post operation.

Interventions

Sample Collection OTHER

Blood and urine samples will be collected for research purposes along with the routinely collected blood and urine samples that are collected as part of the standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of age 18 or older, who are undergoing scheduled adult cardiac surgery, who are not having heart transplantation, and do not have a ventricular assist device prior to surgery.

You may qualify if:

• Age \>/= 18 years, Scheduled adult cardiac surgery

You may not qualify if:

• Age \< 18 years, heart transplantation, presence of preoperative ventricular assist device

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum and urine samples will be collected for each participant.

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Benjamin Tuck, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: June 1, 2019
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)