Personalized Blood Transfusion Protocol for Cardiac Patients

Part of paid clinical trials in Palo Alto, California.

Sponsor
Yan Mia Min
Study ID
NCT07671469
Status
Not Yet Recruiting

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Conditions

  • Anemia
  • Blood Transfusion
  • Cardiac Surgery
  • Cardiopulmonary Bypass

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 14, 2026
Status verified
Jun 2026
Primary completion
Oct 19, 2029
Completion
Mar 15, 2030

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Restrictive Threshold (Control)
    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.
  • Experimental: Demand-Informed (Personalized) Strategy (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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterPalo AltoCalifornia94305-

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By research site
Stanford University Medical Center· Palo Alto, CA

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