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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demand-Informed Transfusion Decision Rule | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | In-hospital for the index procedure or within 28 days of surgery, whichever is longer |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Min, MD, PhD | Contact | 650-666-9504 | yanmin@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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. | 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). | 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. | 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. | 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). | Through 28 days postoperatively |
| Number of participants with a postoperative infection | Through 28 days postoperatively |
| Duration of intensive care unit stay | From ICU admission to ICU discharge, up to 28 days |
| Duration of hospital stay | From surgery to hospital discharge, an average of up to 28 days |