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NCT Number: NCT07671469

Personalized 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.

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Key information

Conditions

Cardiac Surgery Anemia Blood Transfusion Cardiopulmonary Bypass Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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)

Treatment and study plan

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.

Other names: Personalized transfusion strategy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of participants who die from any cause by 6 months after surgery

    Time frame: 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).

  2. 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

    Death from any cause occurring in-hospital during the index-procedure admission or within 28 days of surgery, whichever is longer.

  3. Number of participants with postoperative myocardial infarction

    Time frame: In-hospital or within 28 days of surgery, whichever is longer

    Per the Fourth Universal Definition (Type 5, CABG-related).

  4. Number of participants with postoperative stroke

    Time frame: In-hospital or within 28 days of surgery, whichever is longer

    New central focal neurological deficit confirmed by CT or MRI.

  5. Number of participants with new renal failure requiring dialysis

    Time frame: In-hospital or within 28 days of surgery, whichever is longer

    KDIGO Stage 3 AKI with initiation of renal replacement therapy, in patients not on chronic dialysis preoperatively.

  6. Number of participants with postoperative acute kidney injury

    Time frame: Through 28 days postoperatively

    AKI defined by KDIGO criteria (any stage).

  7. Number of participants with a postoperative infection

    Time frame: Through 28 days postoperatively

  8. Duration of intensive care unit stay

    Time frame: From ICU admission to ICU discharge, up to 28 days

  9. Duration of hospital stay

    Time frame: From surgery to hospital discharge, an average of up to 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Min, MD, PhD

CONTACT

[email protected]

650-666-9504

Sponsors and collaborators

Lead sponsor

Yan Mia Min

Other

Collaborators

  • Stanford University

Registry information

Official study title

Personalized (Demand-Informed) Blood Transfusion Protocol for Cardiac Patients

Acronym: PerP

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 26, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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