An interventional study of Demand-Informed Transfusion Decision Rule in Cardiac Surgery, Blood Transfusion and Anemia, sponsored by Yan Mia Min. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Yan Mia Min · Not applicable, Interventional, and Treatment
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's planned enrollment of 900 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →This is the only study on the registry with Yan Mia Min as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Demand-Informed Transfusion Decision Rule
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.
Other: Demand-Informed Transfusion Decision Rule
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.
Also known as: Personalized transfusion strategy
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.
Time frame: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.