Personalized Blood Transfusion Protocol for Cardiac Patients

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis [Срок оценки: In-hospital for the index procedure or within 28 days of surgery, whichever is longer]

Вторичные конечные точки (9)

• Number of participants who die from any cause by 6 months after surgery [Срок оценки: 6 months after surgery]
• Number of participants who die (all-cause surgical mortality) [Срок оценки: In-hospital for the index procedure or within 28 days of surgery, whichever is longer]
• Number of participants with postoperative myocardial infarction [Срок оценки: In-hospital or within 28 days of surgery, whichever is longer]
• Number of participants with postoperative stroke [Срок оценки: In-hospital or within 28 days of surgery, whichever is longer]
• Number of participants with new renal failure requiring dialysis [Срок оценки: In-hospital or within 28 days of surgery, whichever is longer]
• Number of participants with postoperative acute kidney injury [Срок оценки: Through 28 days postoperatively]
• Number of participants with a postoperative infection [Срок оценки: Through 28 days postoperatively]
• Duration of intensive care unit stay [Срок оценки: From ICU admission to ICU discharge, up to 28 days]
• Duration of hospital stay [Срок оценки: From surgery to hospital discharge, an average of up to 28 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford University Medical Center — Palo Alto

Идентификаторы

NCT: NCT07671469 · 84310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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