Anemia, Blood Transfusion, Cardiac Surgery, Cardiopulmonary Bypass
Conditions
Keywords
restrictive transfusion, hemoglobin trhreshold, oxygen delivery, cardiac surgery, ICU
Brief summary
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
OTHERDemand-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.
Sponsors
Yan Mia Min
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who die from any cause by 6 months after surgery | 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). |
| Number of participants who die (all-cause surgical mortality) | 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. |
| Number of participants with postoperative myocardial infarction | In-hospital or within 28 days of surgery, whichever is longer | Per the Fourth Universal Definition (Type 5, CABG-related). |
| Number of participants with postoperative stroke | In-hospital or within 28 days of surgery, whichever is longer | New central focal neurological deficit confirmed by CT or MRI. |
| Number of participants with new renal failure requiring dialysis | 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. |
| Number of participants with postoperative acute kidney injury | Through 28 days postoperatively | AKI defined by KDIGO criteria (any stage). |
| 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 | — |
Countries
United States
Contacts
CONTACTYan Min, MD, PhD
Outcome results
None listed