Personalized Blood Transfusion Protocol for Cardiac Patients

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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]

Secondary outcome measures (9)

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Stanford University Medical Center — Palo Alto

Identifiers

NCT: NCT07671469 · 84310

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗