Patient Blood ManagementNCT05078086
Study on the Relationship of Arterial-venous Oxygen Difference and Postoperative Complications After Cardiac Surgery.
An observational study of Patient Blood Management and Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Avoidance of unnecessary blood transfusions has always been a focus of clinical research. The rate of perioperative red blood cell transfusion in patients undergoing cardiac surgery under cardiopulmonary bypass reaches between 50-70%, and the intraoperative red blood cell transfusion rate is 30-50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Blood Management, Cardiac Surgery, Transfusion
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to 30 May 2023
- How long will I take part?
- 1 Year
- 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: Moderate to high risk patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
Who may be able to join
- Over 18 years old
- Cardiovascular surgery patients with cardiopulmonary bypass
- Preoperative EuroSCORE I≥6（European System for Cardiac Operative Risk Evaluation)
- Obtained informed consent
Who cannot join
- Patients who cannot accept blood products
- Patients who refuse to accept transfusion
- Patients with autologous blood reserve before surgery
- Patients who are going to receive heart transplantation or have undergone heart transplantation
- Patients who have undergone ventricular assist device implantation surgery
- Patients who refuse to participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
About this study
Avoidance of unnecessary blood transfusions has always been a focus of clinical research. The rate of perioperative red blood cell transfusion in patients undergoing cardiac surgery under cardiopulmonary bypass reaches between 50-70%, and the intraoperative red blood cell transfusion rate is 30-50%. Regarding whether and when to perform a blood transfusion, it is necessary to comprehensively consider the benefits and risks brought by blood transfusion.
Previous studies on blood transfusion strategies have mainly focused on the hemoglobin threshold, but the hemoglobin level does not fully reflect the level of tissue oxygenation. Mixed venous blood oxygen saturation has been widely studied as a valuable indicator reflecting the balance of oxygen delivery and oxygen consumption. But due to the difficulty of placing a pulmonary artery floating catheter for monitoring, its clinical application is limited. Central venous oxygen saturation requires only a small collection of blood samples, which can reflect the oxygen saturation of the superior vena cava, and studies have shown that it can effectively guide the blood transfusion of patients undergoing cardiac surgery. Existing studies have shown that in critically ill patients, the use of arterial-venous oxygen difference > 3.7 mL as an indicator to guide blood transfusion can lead to a higher 90-day survival rate. However, the relationship between the arterial-venous oxygen difference and the incidence of adverse events in cardiac surgery patients under CPB remains unclear. Whether increasing the arterial-venous oxygen difference during surgery can reduce the incidence of postoperative adverse events remains to be clarified.
This study intends to collect intraoperative arterial blood and central venous blood samples from cardiac surgery patients undergoing CPB, and analyze the relationship between arterial-venous oxygen difference and the incidence of postoperative adverse events.
Read the detailed description
The >18 y/o patients who undergo cardiac surgery with cardiopulmonary bypass and with a preoperative additive EuroSCORE I≥ 6 are enrolled. Blood samples will be collected through arteries and central venous at the following intraoperative time points: before CPB, during CPB, and after CPB. The observation will end by hospital discharge or 28 days after surgery, whichever came first. The follow-up will continue for one year after surgery.
- Conditions
- Patient Blood Management, Cardiac Surgery, Transfusion
- Being tested
- No intervention
- Keywords
- arterial-venous oxygen difference, Patient blood management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiac surgery with CPB | >18 y/o patients who undergo cardiac surgery with cardiopulmonary bypass and with a preoperative additive EuroSCORE I≥ 6 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of mortality and serious morbidity (cardiac, renal, and neurological events)
Composite incidence of any one of the following events occurring during the hospitalization : (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (stroke)
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Secondary outcomes (13)
Incidence of any independent component of the primary outcome
Incidence of any independent component of the primary outcome (all-cause mortality, myocardial infarction, new renal failure requiring dialysis, and new focal neurological deficit (stroke))
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Blood product transfusion
Time, category, and volume of blood product transfusion
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Length of stay in ICU
Length of stay in ICU after surgery
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Total length of hospital stay after surgery
Total length of hospital stay after surgery
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Duration of mechanical ventilation after surgery
Total length of hospital stay after surgery
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Occurrence of low cardiac output after surgery
Need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Infection
Infection will be defined as septic shock with positive blood cultures; pneumonia defined as autopsy diagnosis or roentgenographic infiltrate and at least two of the following three criteria: fever, leukocytosis, and positive sputum culture; and/or deep sternal or leg wound infection requiring intravenous antibiotics and/or surgical debridement
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Gut infarction
confirmed by imaging, autopsy, or through surgical means
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Acute kidney injury
AKI defined by the KDIGO
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Seizures
Defined as generalized or focal tonic-clonic movements consistent with seizure; or EEG demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Delirium
Based on one of the following criteria: CAM-ICU/ CAM (even on 1 occasion) or ICDSC > 3 or more than one dose of haloperidol or similar antipsychotic drug or documented delirium by neurologist or neurosurgeon or psychiatrist consultation
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Encephalopathy
Defined as unexpected delayed awakening or severely altered mental status (unconscious despite no sedative medication for more than 5 days), or encephalopathy documented by neurologist or neurosurgeon or psychiatrist consultation
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Reoperation rate
The rate of reoperation
Measured: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start18 Oct 2021
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Blood ManagementStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Yan, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Min Yan, Doctor, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078086
- Sponsor's protocol ID
- 2021-0486
- Status last verified
- Jan 2025
- First submitted
- 27 Sep 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship of Arterial-venous Oxygen Difference and Postoperative Complications After Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT05078086
- Acronym / sponsor ID
- 2021-0486
- Conditions
- Patient Blood Management, Cardiac Surgery, Transfusion
- Keywords
- arterial-venous oxygen difference, Patient blood management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 14 Oct 2021 (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.
Avoidance of unnecessary blood transfusions has always been a focus of clinical research. The rate of perioperative red blood cell transfusion in patients undergoing cardiac surgery under cardiopulmonary bypass reaches between 50-70%, and the intraoperative red blood cell transfusion rate is 30-50%. Regarding whether and when to perform a blood transfusion, it is necessary to comprehensively consider the benefits and risks brought by blood transfusion.
Previous studies on blood transfusion strategies have mainly focused on the hemoglobin threshold, but the hemoglobin level does not fully reflect the level of tissue oxygenation. Mixed venous blood oxygen saturation has been widely studied as a valuable indicator reflecting the balance of oxygen delivery and oxygen consumption. But due to the difficulty of placing a pulmonary artery floating catheter for monitoring, its clinical application is limited. Central venous oxygen saturation requires only a small collection of blood samples, which can reflect the oxygen saturation of the superior vena cava, and studies have shown that it can effectively guide the blood transfusion of patients undergoing cardiac surgery. Existing studies have shown that in critically ill patients, the use of arterial-venous oxygen difference > 3.7 mL as an indicator to guide blood transfusion can lead to a higher 90-day survival rate. However, the relationship between the arterial-venous oxygen difference and the incidence of adverse events in cardiac surgery patients under CPB remains unclear. Whether increasing the arterial-venous oxygen difference during surgery can reduce the incidence of postoperative adverse events remains to be clarified.
This study intends to collect intraoperative arterial blood and central venous blood samples from cardiac surgery patients undergoing CPB, and analyze the relationship between arterial-venous oxygen difference and the incidence of postoperative adverse events.
Detailed description
The >18 y/o patients who undergo cardiac surgery with cardiopulmonary bypass and with a preoperative additive EuroSCORE I≥ 6 are enrolled. Blood samples will be collected through arteries and central venous at the following intraoperative time points: before CPB, during CPB, and after CPB. The observation will end by hospital discharge or 28 days after surgery, whichever came first. The follow-up will continue for one year after surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac surgery with CPB | – | Other: No intervention>18 y/o patients who undergo cardiac surgery with cardiopulmonary bypass and with a preoperative additive EuroSCORE I≥ 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to high risk patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
Key inclusion criteria (4 listed)
- Over 18 years old
- Cardiovascular surgery patients with cardiopulmonary bypass
- Preoperative EuroSCORE I≥6（European System for Cardiac Operative Risk Evaluation)
- Obtained informed consent
Key exclusion criteria (6 listed)
- Patients who cannot accept blood products
- Patients who refuse to accept transfusion
- Patients with autologous blood reserve before surgery
- Patients who are going to receive heart transplantation or have undergone heart transplantation
- Patients who have undergone ventricular assist device implantation surgery
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 |
|---|---|---|
| No interventionNo intervention | Other | Patients undergoing cardiac surgery with CPB |
Primary outcome
Composite outcome of mortality and serious morbidity (cardiac, renal, and neurological events)
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Composite incidence of any one of the following events occurring during the hospitalization : (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (stroke)
13 secondary outcomes
Incidence of any independent component of the primary outcome
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Blood product transfusion
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Length of stay in ICU
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Total length of hospital stay after surgery
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Duration of mechanical ventilation after surgery
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Occurrence of low cardiac output after surgery
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Infection
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Gut infarction
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Acute kidney injury
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Seizures
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Delirium
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Encephalopathy
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Reoperation rate
Time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
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 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Patient Blood Management
Not yet recruitingObservational study
Patient Blood Management in Obstetrics
Patient Blood Management, Blood Product Transfusion for All Conditions
Recruiting
Effect of the Combined Programme on Perioperative Anaemia（CPPA）
Patient Blood Management, Cardiac Surgery
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.
Min Yan, Doctor principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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 Patient Blood Management and Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 inclusion and 6 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 28 Jan 2025. 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 China. 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 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?
Composite outcome of mortality and serious morbidity (cardiac, renal, and neurological events) (time frame: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first). 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 28 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.