Adult Cardiac SurgeryNCT04043507
Non-Encapsulated Heme Levels in Adult Cardiac Surgery
An observational study of Adult Cardiac Surgery, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Cardiac Surgery
- What is being tested?
- Sample Collection
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 14 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age >/= 18 years, Scheduled adult cardiac surgery
Who cannot join
- Age < 18 years, heart transplantation, presence of preoperative ventricular assist device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the detailed description
Previous investigations have demonstrated increased levels of free heme in patients undergoing coronary artery bypass grafting utilizing cardiopulmonary bypass. There is evidence of an association between elevations in free heme levels and risk of developing acute kidney injury. The degree of alterations in free heme levels and the heme metabolism pathway in patients undergoing valvular repair or replacement, durable mechanical ventricular assist device placement, or aortic aneurysm repair has not been well characterized. Furthermore, free heme levels after coronary artery bypass grafting without utilization of cardiopulmonary bypass have not been described previously. Cell salvage techniques independent of cardiopulmonary bypass are known to be potentially traumatic to the cellular components of blood and this relationship has not been thoroughly explored in the cardiac surgery population. Lastly, there is scarce prior work attempting to assess the interplay between free heme levels and novel biomarkers of acute kidney injury.
- Conditions
- Adult Cardiac Surgery
- Being tested
- Sample Collection
- Keywords
- Heme, Cardiac, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample CollectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Jun 2019
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Why it stopped: Lab equipment issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin C. Tuck, University of Alabama at Birmingham
- Investigators
- Benjamin Tuck, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043507
- Sponsor's protocol ID
- 300002894
- Other IDs
- UAB
- Status last verified
- Oct 2024
- First submitted
- 31 Jul 2019
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Encapsulated Heme Levels in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04043507
- Acronym / sponsor ID
- 300002894
- Conditions
- Adult Cardiac Surgery
- Keywords
- Heme, Cardiac, Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lab equipment issue
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Previous investigations have demonstrated increased levels of free heme in patients undergoing coronary artery bypass grafting utilizing cardiopulmonary bypass. There is evidence of an association between elevations in free heme levels and risk of developing acute kidney injury. The degree of alterations in free heme levels and the heme metabolism pathway in patients undergoing valvular repair or replacement, durable mechanical ventricular assist device placement, or aortic aneurysm repair has not been well characterized. Furthermore, free heme levels after coronary artery bypass grafting without utilization of cardiopulmonary bypass have not been described previously. Cell salvage techniques independent of cardiopulmonary bypass are known to be potentially traumatic to the cellular components of blood and this relationship has not been thoroughly explored in the cardiac surgery population. Lastly, there is scarce prior work attempting to assess the interplay between free heme levels and novel biomarkers of acute kidney injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age >/= 18 years, Scheduled adult cardiac surgery
Key exclusion criteria (1 listed)
- Age < 18 years, heart transplantation, presence of preoperative ventricular assist device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample CollectionBlood 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. | Other | – |
Primary outcome
Red Blood Cell Stability
Time frame: 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.
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.
Results and safety
The study was stopped early (reason given: Lab equipment issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Tuck, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Cardiac Surgery, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lab equipment issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red Blood Cell Stability (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.