Cardiac SurgeryPerPNCT07671469
Personalized Blood Transfusion Protocol for Cardiac Patients
A study testing Demand-Informed Transfusion Decision Rule in people with Cardiac Surgery and Blood Transfusion, run by Yan Mia Min at 1 site in United States.
Trial summary
This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Blood Transfusion, Anemia
- What is being tested?
- Demand-Informed Transfusion Decision Rule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to 15 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults 18 years or older scheduled for cardiac surgery using the heart-lung machine (cardiopulmonary bypass), such as bypass, valve, or combined procedures
- Moderate-to-high surgical risk (e.g., EuroSCORE II ≥ 3% or equivalent)
- Allogeneic red blood cell transfusion is considered likely
- Able to provide informed consent and understand randomization to different transfusion thresholds
- Willing to receive blood products and follow study transfusion thresholds from anesthesia induction until hospital discharge or day 28, whichever comes first
Who cannot join
- Refusal of or contraindication to allogeneic blood (e.g., Jehovah's Witness or formal directive against transfusion), or enrollment in a preoperative autologous donation program
- Emergency or salvage procedures where protocol triggers are impractical (e.g., active arrest, aortic dissection with collapse)
- Heart transplantation, durable ventricular assist device implantation, or surgery solely for VAD insertion
- Off-pump bypass or other procedures not using cardiopulmonary bypass
- Severe preoperative anemia (e.g., hemoglobin < 8 g/dL) or chronic transfusion-dependent anemia
- Conditions preventing protocol adherence (e.g., anticipated massive hemorrhage, known bleeding disorder, very low platelets, uninterruptible dual antiplatelet/anticoagulant therapy)
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- Chronic dialysis dependence or established end-stage renal disease (eGFR < 15 mL/min/1.73m² or on maintenance renal replacement therapy) prior to surgery.
- Pregnancy or lactation
- Enrollment in another interventional trial affecting transfusion practice or hemoglobin thresholds
- Unable to provide informed consent (e.g., severe cognitive impairment without a legally authorized representative)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University Medical Center
Palo Alto, California, 94305
About this study
Official title: Personalized (Demand-Informed) Blood Transfusion Protocol for Cardiac Patients
This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. The other approach adds each patient's own physiology - such as oxygen levels and lactate - to help decide whether a transfusion is truly needed, within a safe range. The investigators want to learn whether the personalized approach is as safe as the standard approach for major outcomes after heart surgery, while reducing the amount of blood transfused. Participants may also choose to give blood and stool samples to a research biobank for future studies on recovery after cardiac surgery.
- Conditions
- Cardiac Surgery, Blood Transfusion, Anemia, Cardiopulmonary Bypass
- Being tested
- Demand-Informed Transfusion Decision Rule
- Keywords
- restrictive transfusion, hemoglobin trhreshold, oxygen delivery, cardiac surgery, ICU
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demand-Informed Transfusion Decision RuleOther
Also called Personalized transfusion strategy
A deterministic, rules-based clinical decision aid that operationalizes the assigned ICU transfusion strategy using values already collected in routine care. It contains no trained model or machine learning; it is advisory and can be hand-executed at the bedside.
| Study group | Role | What they receive |
|---|---|---|
| Standard Restrictive Threshold (Control) | Active comparator | Beginning on arrival to the cardiac ICU after surgery, transfusion of red blood cells is generally recommended when hemoglobin is below 7.5 g/dL, consistent with current institutional practice and major restrictive-threshold trials. Standard surgical, anesthesia, perfusion, monitoring, and postoperative care are provided to all participants. Receives: Other: Demand-Informed Transfusion Decision Rule |
| Demand-Informed (Personalized) Strategy (Experimental) | Experimental | Beginning on arrival to the cardiac ICU, an absolute safety floor recommends transfusion when hemoglobin is below 7.0 g/dL regardless of physiology. Between 7.0 and 7.5 g/dL, transfusion decisions are guided by predefined physiologic markers of oxygen balance (e.g., indexed oxygen delivery, venous oxygen saturation, lactate trends): transfusion may be deferred when markers indicate adequate oxygen delivery and is recommended when markers indicate compromised delivery. At or above 7.5 g/dL the rule does not recommend transfusion. The rule is advisory; clinicians may override at any time, and overrides are recorded. Receives: Other: Demand-Informed Transfusion Decision Rule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
Composite event = occurrence of any one of the following, each component also reported separately:
All-cause mortality - death from any cause occurring in-hospital during the index-procedure admission or within 28 days of surgery, whichever is longer.
Myocardial infarction - per the Fourth Universal Definition of Myocardial Infarction (Type 5, CABG-related, applying the post-cardiac-surgery biomarker thresholds together with supporting ECG, imaging, or angiographic evidence).
Stroke - a new focal neurological deficit of central origin lasting ≥24 hours (or <24 hours with confirmatory neuroimaging), confirmed by CT or MRI.
New renal failure requiring dialysis - new acute kidney injury meeting KDIGO Stage 3 criteria with initiation of renal replacement therapy in a patient not previously on chronic dialysis.
Measured: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
Secondary outcomes (9)
Number of participants who die from any cause by 6 months after surgery
All-cause mortality assessed at 6 months postoperatively. This is the principal longer-term safety endpoint: anemia- and transfusion-related harms in cardiac surgery often manifest after the index hospitalization, so 6-month mortality is the most sensitive single test of whether the personalized strategy is as safe as the standard strategy (consistent with the primary endpoints of TRICS-III and TITRe2).
Measured: 6 months after surgery
Number of participants who die (all-cause surgical mortality)
Death from any cause occurring in-hospital during the index-procedure admission or within 28 days of surgery, whichever is longer.
Measured: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
Number of participants with postoperative myocardial infarction
Per the Fourth Universal Definition (Type 5, CABG-related).
Measured: In-hospital or within 28 days of surgery, whichever is longer
Number of participants with postoperative stroke
New central focal neurological deficit confirmed by CT or MRI.
Measured: In-hospital or within 28 days of surgery, whichever is longer
Number of participants with new renal failure requiring dialysis
KDIGO Stage 3 AKI with initiation of renal replacement therapy, in patients not on chronic dialysis preoperatively.
Measured: In-hospital or within 28 days of surgery, whichever is longer
Number of participants with postoperative acute kidney injury
AKI defined by KDIGO criteria (any stage).
Measured: Through 28 days postoperatively
Number of participants with a postoperative infection
Measured: Through 28 days postoperatively
Duration of intensive care unit stay
Measured: From ICU admission to ICU discharge, up to 28 days
Duration of hospital stay
Measured: From surgery to hospital discharge, an average of up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start14 Sep 2026 (estimated)
- Primary completion19 Oct 2029 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Mia Min
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor-investigator, Yan Mia Min, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671469
- Sponsor's protocol ID
- 84310
- Acronym
- PerP
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized (Demand-Informed) Blood Transfusion Protocol for Cardiac Patients
- ClinicalTrials.gov ID
- NCT07671469
- Acronym / sponsor ID
- PerP / 84310
- Conditions
- Cardiac Surgery, Blood Transfusion, Anemia, Cardiopulmonary Bypass
- Keywords
- restrictive transfusion, hemoglobin trhreshold, oxygen delivery, cardiac surgery, ICU
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Yan Mia MinUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 19 Oct 2029 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 26 Jun 2026 (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.
This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. The other approach adds each patient's own physiology - such as oxygen levels and lactate - to help decide whether a transfusion is truly needed, within a safe range. The investigators want to learn whether the personalized approach is as safe as the standard approach for major outcomes after heart surgery, while reducing the amount of blood transfused. Participants may also choose to give blood and stool samples to a research biobank for future studies on recovery after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Restrictive Threshold (Control) | Active comparator | Other: Demand-Informed Transfusion Decision RuleBeginning on arrival to the cardiac ICU after surgery, transfusion of red blood cells is generally recommended when hemoglobin is below 7.5 g/dL, consistent with current institutional practice and major restrictive-threshold trials. Standard surgical, anesthesia, perfusion, monitoring, and postoperative care are provided to all participants. |
| Demand-Informed (Personalized) Strategy (Experimental) | Experimental | Other: Demand-Informed Transfusion Decision RuleBeginning on arrival to the cardiac ICU, an absolute safety floor recommends transfusion when hemoglobin is below 7.0 g/dL regardless of physiology. Between 7.0 and 7.5 g/dL, transfusion decisions are guided by predefined physiologic markers of oxygen balance (e.g., indexed oxygen delivery, venous oxygen saturation, lactate trends): transfusion may be deferred when markers indicate adequate oxygen delivery and is recommended when markers indicate compromised delivery. At or above 7.5 g/dL the rule does not recommend transfusion. The rule is advisory; clinicians may override at any time, and overrides are recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years or older scheduled for cardiac surgery using the heart-lung machine (cardiopulmonary bypass), such as bypass, valve, or combined procedures
- Moderate-to-high surgical risk (e.g., EuroSCORE II ≥ 3% or equivalent)
- Allogeneic red blood cell transfusion is considered likely
- Able to provide informed consent and understand randomization to different transfusion thresholds
- Willing to receive blood products and follow study transfusion thresholds from anesthesia induction until hospital discharge or day 28, whichever comes first
Key exclusion criteria (10 listed)
- Refusal of or contraindication to allogeneic blood (e.g., Jehovah's Witness or formal directive against transfusion), or enrollment in a preoperative autologous donation program
- Emergency or salvage procedures where protocol triggers are impractical (e.g., active arrest, aortic dissection with collapse)
- Heart transplantation, durable ventricular assist device implantation, or surgery solely for VAD insertion
- Off-pump bypass or other procedures not using cardiopulmonary bypass
- Severe preoperative anemia (e.g., hemoglobin < 8 g/dL) or chronic transfusion-dependent anemia
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 |
|---|---|---|
| Demand-Informed Transfusion Decision RuleAlso: Personalized transfusion strategyA deterministic, rules-based clinical decision aid that operationalizes the assigned ICU transfusion strategy using values already collected in routine care. It contains no trained model or machine learning; it is advisory and can be hand-executed at the bedside. | Other | Demand-Informed (Personalized) Strategy (Experimental), Standard Restrictive Threshold (Control) |
Primary outcome
Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
Time frame: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
Composite event = occurrence of any one of the following, each component also reported separately: All-cause mortality - death from any cause occurring in-hospital during the index-procedure admission or within 28 days of surgery, whichever is longer. Myocardial infarction - per the Fourth Universal Definition of Myocardial Infarction (Type 5, CABG-related, applying the post-cardiac-surgery biomarker thresholds together with supporting ECG, imaging, or angiographic evidence). Stroke - a new focal neurological deficit of central origin lasting ≥24 hours (or <24 hours with confirmatory neuroimaging), confirmed by CT or MRI. New renal failure requiring dialysis - new acute kidney injury meeting KDIGO Stage 3 criteria with initiation of renal replacement therapy in a patient not previously on chronic dialysis.
9 secondary outcomes
Number of participants who die from any cause by 6 months after surgery
Time frame: 6 months after surgery
Number of participants who die (all-cause surgical mortality)
Time frame: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
Number of participants with postoperative myocardial infarction
Time frame: In-hospital or within 28 days of surgery, whichever is longer
Number of participants with postoperative stroke
Time frame: In-hospital or within 28 days of surgery, whichever is longer
Number of participants with new renal failure requiring dialysis
Time frame: In-hospital or within 28 days of surgery, whichever is longer
Number of participants with postoperative acute kidney injury
Time frame: Through 28 days postoperatively
Number of participants with a postoperative infection
Time frame: Through 28 days postoperatively
Duration of intensive care unit stay
Time frame: From ICU admission to ICU discharge, up to 28 days
Duration of hospital stay
Time frame: From surgery to hospital discharge, an average of up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demand-Informed Transfusion Decision Rule in people with Cardiac Surgery and Blood Transfusion, run by Yan Mia Min 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Min, MD, PhD (650-666-9504, yanmin@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis (time frame: In-hospital for the index procedure or within 28 days of surgery, whichever is longer). 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 30 Jun 2026.