Personalized Blood Transfusion Protocol for Cardiac Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYan Mia Min
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Demand-Informed Transfusion Decision Rule
Other interventionA 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.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Standard Restrictive Threshold (Control)Active comparator 1 intervention
Group B: Demand-Informed (Personalized) Strategy (Experimental)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
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.
Time frame
In-hospital for the index procedure or within 28 days of surgery, whichever is longerSecondary outcomes
1
Number of participants who die from any cause by 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).
Time frame
6 months after surgery2
Number of participants who die (all-cause surgical mortality)
Death from any cause occurring in-hospital during the index-procedure admission or within 28 days of surgery, whichever is longer.
Time frame
In-hospital for the index procedure or within 28 days of surgery, whichever is longer3
Number of participants with postoperative myocardial infarction
Per the Fourth Universal Definition (Type 5, CABG-related).
Time frame
In-hospital or within 28 days of surgery, whichever is longer4
Number of participants with postoperative stroke
New central focal neurological deficit confirmed by CT or MRI.
Time frame
In-hospital or within 28 days of surgery, whichever is longerSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: