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NCT04043507 · ClinicalTrials.gov registry record
Non-Encapsulated Heme Levels in Adult Cardiac Surgery
A clinical trial, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- 3
- Enrollment target
NCT04043507 is a clinical trial that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 3 participants.
The verdict
NCT04043507 was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study 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.
Interventions
- OTHER Sample Collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2024-11-14 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04043507
The ClinicalTrials.gov registry entry for NCT04043507 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sample Collection is the first listed.
NCT04043507 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04043507 about?
NCT04043507 is a clinical study titled "Non-Encapsulated Heme Levels in Adult Cardiac Surgery". 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 blo...
What is the current status of trial NCT04043507?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2019-06-01. Estimated completion is 2024-11-14.
What interventions are being tested in trial NCT04043507?
The interventions under investigation include: Sample Collection (OTHER).
Who is sponsoring clinical trial NCT04043507?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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