Coronary Artery Bypass GraftingPhase 4NCT06835257
Hemodynamic Management in Autologous Blood Collection for CABG Surgery
A Phase 4 study testing Acute normovolemic hemodilutions and Vasopressor infusion in people with Coronary Artery Bypass Grafting and Acute Normovolemic Hemodilution, run by Ataturk University at 2 sites in Turkey (Türkiye).
Trial summary
In this study, investigated the hemodynamic differences between patients who underwent acute normovolemic hemodilution during the Autologous Blood Collection procedure in coronary artery bypass graft surgery and those who did not, using hemodynamic and cardiac data obtained by MostCare's pressure recording analytical… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Bypass Grafting, Acute Normovolemic Hemodilution
- What is being tested?
- Acute normovolemic hemodilutions and Vasopressor infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Oct 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years
- Undergoing isolated coronary artery bypass grafting surgery under general anesthesia
- Invasive blood pressure (radial or femoral) and Mostcare monitoring
- Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery
- Ability and willingness to provide informed consent
Who cannot join
- Refuse to consent to the study
- Arterial wave form distortion
- Cardiac arrhythmia
- Inappropriate identification of the dicrotic notch for any reason
- Hemodynamic instability defined as mean arterial blood pressure < 65 mmHg
- Preoperative requirement of inotrope/vasopressor infusion
Show all 15Show fewer
- Preoperatively receiving vasoactive drugs
- Patients fitted with an intra-aortic balloon pump
- Patients fitted with Extracorporeal Membrane Oxygenation
- Critically ill patients requiring preoperative intensive care unit
- Presence of intraabdominal hypertension
- New York Heart Association Class 3-4 heart failure
- Congestive heart failure with ejection fraction < 35%
- Glomerular filtration rate < 30 ml/min/1.73 m2
- Ongoing renal replacement therapy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ataturk University
Erzurum, Yakutiye, 25100
Ataturk University
Erzurum
About this study
Official title: Evaluation of the Effect of Different Hemodynamic Managements Throughout Autologous Blood Collection Methods on Pulse Contour Analysis Parameters in Coronary Artery Bypass Graft Surgery
In this study, investigated the hemodynamic differences between patients who underwent acute normovolemic hemodilution during the Autologous Blood Collection procedure in coronary artery bypass graft surgery and those who did not, using hemodynamic and cardiac data obtained by MostCare's pressure recording analytical method (PRAM).
Read the detailed description
Coronary artery bypass graft (CABG) surgeries are surgeries in which the need for blood transfusion is high. Allogeneic transfusion and transfusion-related complications have led researchers to use different techniques. Autologous blood collection method is one of the alternative methods used to eliminate the need for transfusion. The acute normovolemic hemodilution technique traditionally applied during autologous blood collection causes hemodilution in CABG surgeries and increases the risk of bleeding in patients. In this study, vasopressor infusion technique was used as an alternative technique to avoid hemodilution during autologous blood collection. These two techniques (Acute normovolemic hemodilution - Vasopressor infusion) applied to maintain hemodynamic stabilization during autologous blood collection were compared with the advanced cardiac and hemodynamic data provided by the pressure recording analytical method. The primary aim of the study was to compare cardiac cycle efficiency (CCE), which is a cardiac performance parameter and provides estimates of the energy spent by the cardiovascular system to maintain hemodynamic balance. Secondary objectives are to compare other advanced hemodynamic and postoperative laboratory parameters.
- Being tested
- Acute normovolemic hemodilutions, Vasopressor infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute normovolemic hemodilutionsProcedure or surgery
Crystalloid infusion throughout the autologous blood collection (3 ml of crystalloid infusion for every 1 ml of blood)
Vasopressor infusionDrug
Vasopressor infusion throughout the autologous blood collection (according to mean arterial pressure)
| Study group | Role | What they receive |
|---|---|---|
| Acute normovolemic hemodilution | Active comparator | Acute normovolemic hemodilution throughout the autologous blood collection Receives: Procedure: Acute normovolemic hemodilutions |
| Vasopressor | Active comparator | Vasopressor infusion throughout the autologous blood collection Receives: Drug: Vasopressor infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effects of different techniques used for autologous blood collection on Cardiac Cycle Efficiency (CCE) changes obtained by pulse contour analysis.
Difference of Cardiac Cycle Efficiency(CCE) PRAM parameters between patients
Measured: From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)
Secondary outcomes (1)
Comparison of the Contractility (dP/dtmax mmHg/msec), Stroke Volume Index (SVI mL/m2), Cardiac Power Index (CPI W/m2), Arterial Elastance (Ea mmHg/mL), Stroke Volume Variation (SVV %), Pulse Pressure Variation (PPV %) changes
Difference of other PRAM and traditional hemodynamic parameters between patients
Measured: From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jun 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed E Aydin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835257
- Sponsor's protocol ID
- ATATURK-Hemodynamic
- Status last verified
- Feb 2025
- First submitted
- 22 Aug 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett-Guerrero E, Zhao Y, O'Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA. 2010 Oct 13;304(14):1568-75. doi: 10.1001/jama.2010.1406.
PubMed 20940382Coursin DB, Monk TG. Extreme normovolemic hemodilution: how low can you go and other alternatives to transfusion? Crit Care Med. 2001 Apr;29(4):908-10. doi: 10.1097/00003246-200104000-00051. No abstract available.
PubMed 11373498Romano SM, Pistolesi M. Assessment of cardiac output from systemic arterial pressure in humans. Crit Care Med. 2002 Aug;30(8):1834-41. doi: 10.1097/00003246-200208000-00027.
PubMed 12163802
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Hemodynamic Managements Throughout Autologous Blood Collection Methods on Pulse Contour Analysis Parameters in Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06835257
- Acronym / sponsor ID
- ATATURK-Hemodynamic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 19 Feb 2025 (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.
In this study, investigated the hemodynamic differences between patients who underwent acute normovolemic hemodilution during the Autologous Blood Collection procedure in coronary artery bypass graft surgery and those who did not, using hemodynamic and cardiac data obtained by MostCare's pressure recording analytical method (PRAM).
Detailed description
Coronary artery bypass graft (CABG) surgeries are surgeries in which the need for blood transfusion is high. Allogeneic transfusion and transfusion-related complications have led researchers to use different techniques. Autologous blood collection method is one of the alternative methods used to eliminate the need for transfusion. The acute normovolemic hemodilution technique traditionally applied during autologous blood collection causes hemodilution in CABG surgeries and increases the risk of bleeding in patients. In this study, vasopressor infusion technique was used as an alternative technique to avoid hemodilution during autologous blood collection. These two techniques (Acute normovolemic hemodilution - Vasopressor infusion) applied to maintain hemodynamic stabilization during autologous blood collection were compared with the advanced cardiac and hemodynamic data provided by the pressure recording analytical method. The primary aim of the study was to compare cardiac cycle efficiency (CCE), which is a cardiac performance parameter and provides estimates of the energy spent by the cardiovascular system to maintain hemodynamic balance. Secondary objectives are to compare other advanced hemodynamic and postoperative laboratory parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute normovolemic hemodilution | Active comparator | Procedure: Acute normovolemic hemodilutionsAcute normovolemic hemodilution throughout the autologous blood collection |
| Vasopressor | Active comparator | Drug: Vasopressor infusionVasopressor infusion throughout the autologous blood collection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at least 18 years
- Undergoing isolated coronary artery bypass grafting surgery under general anesthesia
- Invasive blood pressure (radial or femoral) and Mostcare monitoring
- Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery
- Ability and willingness to provide informed consent
Key exclusion criteria (15 listed)
- Refuse to consent to the study
- Arterial wave form distortion
- Cardiac arrhythmia
- Inappropriate identification of the dicrotic notch for any reason
- Hemodynamic instability defined as mean arterial blood pressure < 65 mmHg
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 |
|---|---|---|
| Acute normovolemic hemodilutionsCrystalloid infusion throughout the autologous blood collection (3 ml of crystalloid infusion for every 1 ml of blood) | Procedure or surgery | Acute normovolemic hemodilution |
| Vasopressor infusionVasopressor infusion throughout the autologous blood collection (according to mean arterial pressure) | Drug | Vasopressor |
Primary outcome
Comparison of the effects of different techniques used for autologous blood collection on Cardiac Cycle Efficiency (CCE) changes obtained by pulse contour analysis.
Time frame: From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)
Difference of Cardiac Cycle Efficiency(CCE) PRAM parameters between patients
1 secondary outcome
Comparison of the Contractility (dP/dtmax mmHg/msec), Stroke Volume Index (SVI mL/m2), Cardiac Power Index (CPI W/m2), Arterial Elastance (Ea mmHg/mL), Stroke Volume Variation (SVV %), Pulse Pressure Variation (PPV %) changes
Time frame: From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 20940382Bennett-Guerrero E, Zhao Y, O'Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK. Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA. 2010 Oct 13;304(14):1568-75. doi: 10.1001/jama.2010.1406.
- Background: PubMed 11373498Coursin DB, Monk TG. Extreme normovolemic hemodilution: how low can you go and other alternatives to transfusion? Crit Care Med. 2001 Apr;29(4):908-10. doi: 10.1097/00003246-200104000-00051. No abstract available.
- Background: PubMed 12163802Romano SM, Pistolesi M. Assessment of cardiac output from systemic arterial pressure in humans. Crit Care Med. 2002 Aug;30(8):1834-41. doi: 10.1097/00003246-200208000-00027.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acute normovolemic hemodilutions and Vasopressor infusion in people with Coronary Artery Bypass Grafting and Acute Normovolemic Hemodilution, run by Ataturk University at 2 sites in Turkey (Türkiye).
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 5 inclusion and 15 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: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the effects of different techniques used for autologous blood collection on Cardiac Cycle Efficiency (CCE) changes obtained by pulse contour analysis. (time frame: From the beginning to the end of autologous blood collection (in the first 30 minutes of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06835257, which also lists 3 linked publications.
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 19 Feb 2025.