Aortic Valve DiseasePhase 4NCT06235424
Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement
A Phase 4 study testing Del Nido Cardioplegia Solution and HTK solution in people with Aortic Valve Disease and Valve Disease, Heart, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is: Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Valve Disease, Heart, Cardiac Ischemia
- What is being tested?
- Del Nido Cardioplegia Solution and HTK solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2018to 24 Sep 2024
- Phase
- Phase 4
- 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
Who may be able to join
- patients aged 18 and over,
- qualified for elective isolated aortic valve replacement (AVR)
Who cannot join
- patients with significant coronary artery disease,
- urgent cases,
- cases with additional cardiac procedures.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdańsk
Gdansk, Pomeranian Voivodeship, 80-282
About this study
Official title: Comparison of Low Sodium Crystalloid Bretschneider-HTK Cardioplegia With Del Nido Cardioplegia in Patients Undergoing Elective Aortic Valve Replacement - a Prospective Randomized Trial
The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is:
- Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization.
Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.
Read the detailed description
The idea of using del Nido cardioplegia in adult cardiac surgery appeared after many reports proving its safety and efficacy in the paediatric population. Therefore many adult centres started to apply it in everyday practice. Despite its growing popularity and application in different types of cardiac surgeries, there is still an insufficient number of prospective randomized trials which compare del Nido cardioplegia with the Bretschneider-HTK formula in the adult population.
The described problem will be analyzed at different levels in this prospective, randomised study.
Clinical aspects - del Nido and HTK cardioplegia will be compared in terms of intraoperative and postoperative details such as perfusion details and concentration of cardiac enzymes.
Echocardiographic changes - The next step will be revealing potential echocardiographic changes in cardiac function in short- and long-term observations after cardiac surgery.
Metabolic changes - the metabolic profile of amino acids and nucleotide changes after each cardioplegia solution delivery will be analyzed.
Statistical calculations will be performed by a qualified statistician. In the case of binary variables, Fisher's exact test will be used to assess differences between groups. In the case of quantitative variables, the compliance of the distribution with the normal distribution will be tested using the Shapiro-Wilk test. For quantitative variables with a distribution not significantly different from normal, the Student's t-test will be used for comparison between groups. If the distribution differs significantly from the normal distribution, the Mann-Whitney U test (comparisons of two samples) or the Kruskal-Wallis test (comparisons of many samples) will be used. Correlations between variables will be assessed using the Pearson or Spearman method, depending on the distribution of the variables. Repeated-measures ANOVA will be used to assess the variability of biochemical parameters over time.
In all analyses, p<0.05 will be considered as the level of statistical significance.
A comparison of the two cardioplegia solutions would allow assessing whether del Nido provides better cardioprotection than HTK.
- Conditions
- Aortic Valve Disease, Valve Disease, Heart, Cardiac Ischemia
- Being tested
- Del Nido Cardioplegia Solution, HTK solution
- Keywords
- del Nido cardioplegia, Bretschneider HTK cardioplegia, cardioprotection, cardiac surgery, aortic valve replacement
- Medical subject headings
- Aortic Valve Disease, Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Del Nido Cardioplegia SolutionDrug
Also called del Nido, DNC
The route of cardioplegia delivery differed according to surgeons' preferences. The total dosage of cardioplegia depends on the type of cardioplegia. The standard dose of del Nido cardioplegia in our institution is 1000 ml as an initial dose and is delivered with a system pressure of 90-150 mmHg. The solution is prepared by our hospital's pharmacy. At 60. minute of cross-clamp (XC) if XC time was expected to exceed 90 minutes another dose of solution would be delivered. The volume of an additional dose was 500 ml. The temperature of the delivered del Nido cardioplegia was 4*C.
HTK solutionDrug
Also called HTK, Bretschneider-HTK
The route of cardioplegia delivery differed according to surgeons' preferences. The dose of the HTK cardioplegia is calculated with an application of 20 mL/kg rule. It is delivered with a system pressure of 90-150 mmHg. If the XC time exceeds 120 minutes additional dose is given (10 mL/kg rule). The temperature of the delivered crystalloid cardioplegia is 4*C
| Study group | Role | What they receive |
|---|---|---|
| del Nido cardioplegia group | Active comparator | A group of patients that received high potassium cardioplegic solution with the addition of lidocaine, mixed with the patient's blood in 4:1 ratio Receives: Drug: Del Nido Cardioplegia Solution |
| Bretschneider-HTK cardioplegia group | Active comparator | A group of patients that received low sodium cardioplegic solution with the addition of histidine, tryptophan and alpha-ketoglutarate Receives: Drug: HTK solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative CK-MB
concentration of serum creatine kinase-myocardial band (CK-MB)
Measured: measured in the 6th, 24th, and 48th hour postoperatively
postoperative hsTnI
concentration of serum high sensitive cardiac troponin I (hsTnI)
Measured: measured in the 6th, 24th, and 48th hour postoperatively
Secondary outcomes (46)
CPB time
Time of cardiopulmonary bypass (CPB).
Measured: intraoperative
XC time
Time of aortic cross-clamp (XC).
Measured: intraoperative
Reperfusion time
Time of reperfusion (between removal of cross-clamp and weaning from cardiopulmonary bypass).
Measured: intraoperative
Cardioplegia volume
Total volume cardioplegia doses.
Measured: intraoperative
Cardioplegia doses
Number of cardioplegia doses.
Measured: intraoperative
Heart rhythm after XC
Type of heart rhythm after removal of aortic cross-clamp.
Measured: intraoperative
Need for defibrillation
Need for heart defibrillations in case of ventricular fibrillation.
Measured: intraoperative
Number of defibrillations
Number of heart defibrillations in case of ventricular fibrillation.
Measured: intraoperative
Intraoperative lactate concentration
Lactate measured before XC, at the time of the biggest hemodilution, and after CPB.
Measured: intraoperative
Intraoperative pH results
pH measured before XC, at the time of the biggest hemodilution, and after CPB.
Measured: intraoperative
Intraoperative partial pressure of oxygen
Partial pressure of oxygen measured before XC, at the time of the biggest hemodilution, and after CPB.
Measured: intraoperative
Intraoperative partial pressure of carbon dioxide
Partial pressure of carbon dioxide measured before XC, at the time of the biggest hemodilution, and after CPB.
Measured: intraoperative
Intraoperative base deficit
Base deficit measured before XC, at the time of the biggest hemodilution, and after CPB.
Measured: intraoperative
Intraoperative sodium and potassium concentration
Sodium and potassium concentration measured before XC, at the time of the biggest hemodilution, and after CPB.
Measured: intraoperative
Intraoperative amino acids concentrations
Changes of amino acid concentrations in systemic and coronary sinus blood Before the procedure - sample from the peripheral arterial line before the start of the procedure.
During cardiopulmonary bypass - samples from the peripheral arterial line and samples from the coronary sinus at 1. and 5. minute after aortic cross-clamp removal. Blood from the coronary sinus would be collected by cannula for retrograde cardioplegia delivery.
During reperfusion - peripheral arterial line blood sample would be collected after weaning from cardiopulmonary bypass.
Measured: intraoperative
Intraoperative nucleotides concentrations
changes of nucleotides concentrations in systemic and coronary sinus blood Before the procedure - sample from the peripheral arterial line before the start of the procedure.
During cardiopulmonary bypass - samples from the peripheral arterial line and samples from the coronary sinus at 1. and 5. minute after aortic cross-clamp removal. Blood from the coronary sinus would be collected by cannula for retrograde cardioplegia delivery.
During reperfusion - peripheral arterial line blood sample would be collected after weaning from cardiopulmonary bypass.
Measured: intraoperative
Ventilation time
Time of mechanical ventilation after surgery.
Measured: 30 postoperative days
ICU length of stay
Intensive care unit (ICU) length of stay.
Measured: 30 postoperative days
Hospital length of stay
Hospital length of stay.
Measured: 30 postoperative days
Postoperative lactate concentration
Lactate measured at 6th, 24th, and 48th hour postoperatively.
Measured: 30 postoperative days
Postoperative pH results
pH measured at 6th, 24th, and 48th hour postoperatively.
Measured: 30 postoperative days
Postoperative partial pressure of oxygen
Partial pressure of oxygen measured at 6th, 24th, and 48th hour postoperatively.
Measured: 30 postoperative days
Postoperative partial pressure of carbon dioxide
Partial pressure of carbon dioxide measured at 6th, 24th, and 48th hour postoperatively.
Measured: 30 postoperative days
Postoperative base deficit
Base deficit measured at 6th, 24th, and 48th hour postoperatively.
Measured: 30 postoperative days
Postoperative sodium and potassium levels
Sodium and potassium levels measured at 6th, 24th, and 48th hour postoperatively.
Measured: 30 postoperative days
Maximum CRP concentration
Maximum C reactive protein (CRP) concentration measured during hospitalization at our institution.
Measured: 30 postoperative days
Discharge CRP concentration
CRP results at discharge from our institution.
Measured: 30 postoperative days
Maximum creatinine concentration
Maximum creatinine concentration measured during hospitalization at our institution.
Measured: 30 postoperative days
Discharge creatinine concentration
Creatinine results at discharge from our institution.
Measured: 30 postoperative days
Discharge Hb concentration
Hemoglobin (Hb) results at discharge from our institution.
Measured: 30 postoperative days
Discharge Hct concentration
Hematocrit (Hct) results at discharge from our institution.
Measured: 30 postoperative days
Discharge WBC concentration
White blood cells count (WBC) results at discharge from our institution.
Measured: 30 postoperative days
VIS
Vasoactive-inotropic score (VIS) at 6th, 24th, and 48th hour postoperatively.
Measured: 30 postoperative days
Rate of postoperative transfusions
Rate of postoperative blood product transfusions.
Measured: 30 postoperative days
Rate of resternotomy
Rate of bleeding with the need for re-sternotomy during the early postoperative period.
Measured: 30 postoperative days
Rate of pericardial drainage
Rate of pericardial drainages during the early postoperative period.
Measured: 30 postoperative days
Rate of stroke
Rate of stokes during the early postoperative period.
Measured: 30 postoperative days
Rate of myocardial infarction
Rate of myocardial infarction during the early postoperative period.
Measured: 30 postoperative days
Rate of new-onset arrhythmias
Rate of new-onset arrhythmias (atrial fibrillation, heart block) during the early postoperative period.
Measured: 30 postoperative days
In-hospital mortality rate
Rate of postoperative deaths that occurred during initial hospitalization.
Measured: 30 postoperative days
Out-hospital mortality rate
Rate of postoperative deaths that occurred after hospital discharge.
Measured: approx one year postoperatively
Rate of pacemaker implantation
Pacemaker implantation in postoperative period.
Measured: approx one year postoperatively
Rate of secondary hospitalization
Rate of secondary hospitalization due to late complications or other cardiac-related reasons
Measured: approx one year postoperatively
LVEF values changes
Left ventricular ejection fraction (LVEF) will be measured during an echocardiography test before surgery, before discharge and one year after surgery.
Measured: approx one year postoperatively
Diastolic function changes
Diastolic function measured during an echocardiography test before surgery, before discharge and one year after surgery.
Measured: approx one year postoperatively
2STE parameter changes
2STE parameter changes (with special attention put on the ventricular septum, new hypokinetic or akinetic areas) measured during an echocardiography test before surgery, before discharge and one year after surgery.
Measured: approx one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Oct 2018
- Primary completion24 Apr 2023
- Study completion24 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Brzeska MD, Medical University of Gdansk
- Investigators
- Barbara Brzeska, MD, Principal investigator, Medical Univeristy of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235424
- Sponsor's protocol ID
- NKBBN/203/2018
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with an interest in cardioprotection. Data or samples shared will be coded, with no PHI included. The data underlying this article will be shared on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low Sodium Crystalloid Bretschneider-HTK Cardioplegia With Del Nido Cardioplegia in Patients Undergoing Elective Aortic Valve Replacement - a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06235424
- Acronym / sponsor ID
- NKBBN/203/2018
- Conditions
- Aortic Valve Disease, Valve Disease, Heart, Cardiac Ischemia
- Keywords
- del Nido cardioplegia, Bretschneider HTK cardioplegia, cardioprotection, cardiac surgery, aortic valve replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Sep 2024 (estimated)
- First posted
- 31 Jan 2024 (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.
The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is:
- Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization.
Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.
Detailed description
The idea of using del Nido cardioplegia in adult cardiac surgery appeared after many reports proving its safety and efficacy in the paediatric population. Therefore many adult centres started to apply it in everyday practice. Despite its growing popularity and application in different types of cardiac surgeries, there is still an insufficient number of prospective randomized trials which compare del Nido cardioplegia with the Bretschneider-HTK formula in the adult population.
The described problem will be analyzed at different levels in this prospective, randomised study.
Clinical aspects - del Nido and HTK cardioplegia will be compared in terms of intraoperative and postoperative details such as perfusion details and concentration of cardiac enzymes.
Echocardiographic changes - The next step will be revealing potential echocardiographic changes in cardiac function in short- and long-term observations after cardiac surgery.
Metabolic changes - the metabolic profile of amino acids and nucleotide changes after each cardioplegia solution delivery will be analyzed.
Statistical calculations will be performed by a qualified statistician. In the case of binary variables, Fisher's exact test will be used to assess differences between groups. In the case of quantitative variables, the compliance of the distribution with the normal distribution will be tested using the Shapiro-Wilk test. For quantitative variables with a distribution not significantly different from normal, the Student's t-test will be used for comparison between groups. If the distribution differs significantly from the normal distribution, the Mann-Whitney U test (comparisons of two samples) or the Kruskal-Wallis test (comparisons of many samples) will be used. Correlations between variables will be assessed using the Pearson or Spearman method, depending on the distribution of the variables. Repeated-measures ANOVA will be used to assess the variability of biochemical parameters over time.
In all analyses, p<0.05 will be considered as the level of statistical significance.
A comparison of the two cardioplegia solutions would allow assessing whether del Nido provides better cardioprotection than HTK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| del Nido cardioplegia group | Active comparator | Drug: Del Nido Cardioplegia SolutionA group of patients that received high potassium cardioplegic solution with the addition of lidocaine, mixed with the patient's blood in 4:1 ratio |
| Bretschneider-HTK cardioplegia group | Active comparator | Drug: HTK solutionA group of patients that received low sodium cardioplegic solution with the addition of histidine, tryptophan and alpha-ketoglutarate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 and over,
- qualified for elective isolated aortic valve replacement (AVR)
Key exclusion criteria (3 listed)
- patients with significant coronary artery disease,
- urgent cases,
- cases with additional cardiac procedures.
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 |
|---|---|---|
| Del Nido Cardioplegia SolutionAlso: del Nido, DNCThe route of cardioplegia delivery differed according to surgeons' preferences. The total dosage of cardioplegia depends on the type of cardioplegia. The standard dose of del Nido cardioplegia in our institution is 1000 ml as an initial dose and is delivered with a system pressure of 90-150 mmHg. The solution is prepared by our hospital's pharmacy. At 60. minute of cross-clamp (XC) if XC time was expected to exceed 90 minutes another dose of solution would be delivered. The volume of an additional dose was 500 ml. The temperature of the delivered del Nido cardioplegia was 4*C. | Drug | del Nido cardioplegia group |
| HTK solutionAlso: HTK, Bretschneider-HTKThe route of cardioplegia delivery differed according to surgeons' preferences. The dose of the HTK cardioplegia is calculated with an application of 20 mL/kg rule. It is delivered with a system pressure of 90-150 mmHg. If the XC time exceeds 120 minutes additional dose is given (10 mL/kg rule). The temperature of the delivered crystalloid cardioplegia is 4*C | Drug | Bretschneider-HTK cardioplegia group |
Primary outcome
postoperative CK-MB
Time frame: measured in the 6th, 24th, and 48th hour postoperatively
concentration of serum creatine kinase-myocardial band (CK-MB)
postoperative hsTnI
Time frame: measured in the 6th, 24th, and 48th hour postoperatively
concentration of serum high sensitive cardiac troponin I (hsTnI)
46 secondary outcomes
CPB time
Time frame: intraoperative
XC time
Time frame: intraoperative
Reperfusion time
Time frame: intraoperative
Cardioplegia volume
Time frame: intraoperative
Cardioplegia doses
Time frame: intraoperative
Heart rhythm after XC
Time frame: intraoperative
Need for defibrillation
Time frame: intraoperative
Number of defibrillations
Time frame: intraoperative
Intraoperative lactate concentration
Time frame: intraoperative
Intraoperative pH results
Time frame: intraoperative
Intraoperative partial pressure of oxygen
Time frame: intraoperative
Intraoperative partial pressure of carbon dioxide
Time frame: intraoperative
Intraoperative base deficit
Time frame: intraoperative
Intraoperative sodium and potassium concentration
Time frame: intraoperative
Intraoperative amino acids concentrations
Time frame: intraoperative
Intraoperative nucleotides concentrations
Time frame: intraoperative
Ventilation time
Time frame: 30 postoperative days
ICU length of stay
Time frame: 30 postoperative days
Hospital length of stay
Time frame: 30 postoperative days
Postoperative lactate concentration
Time frame: 30 postoperative days
Postoperative pH results
Time frame: 30 postoperative days
Postoperative partial pressure of oxygen
Time frame: 30 postoperative days
Postoperative partial pressure of carbon dioxide
Time frame: 30 postoperative days
Postoperative base deficit
Time frame: 30 postoperative days
Postoperative sodium and potassium levels
Time frame: 30 postoperative days
Maximum CRP concentration
Time frame: 30 postoperative days
Discharge CRP concentration
Time frame: 30 postoperative days
Maximum creatinine concentration
Time frame: 30 postoperative days
Discharge creatinine concentration
Time frame: 30 postoperative days
Discharge Hb concentration
Time frame: 30 postoperative days
Discharge Hct concentration
Time frame: 30 postoperative days
Discharge WBC concentration
Time frame: 30 postoperative days
VIS
Time frame: 30 postoperative days
Rate of postoperative transfusions
Time frame: 30 postoperative days
Rate of resternotomy
Time frame: 30 postoperative days
Rate of pericardial drainage
Time frame: 30 postoperative days
Rate of stroke
Time frame: 30 postoperative days
Rate of myocardial infarction
Time frame: 30 postoperative days
Rate of new-onset arrhythmias
Time frame: 30 postoperative days
In-hospital mortality rate
Time frame: 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with an interest in cardioprotection. Data or samples shared will be coded, with no PHI included. The data underlying this article will be shared on reasonable request.
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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.
Barbara Brzeska, MD principal investigator
Medical Univeristy of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Del Nido Cardioplegia Solution and HTK solution in people with Aortic Valve Disease and Valve Disease, Heart, run by Medical University of Gdansk at 1 site in Poland.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
postoperative CK-MB (time frame: measured in the 6th, 24th, and 48th hour postoperatively). The study lists 2 primary outcomes in all. 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 31 Jan 2024.