Smarter transfusions: tailoring blood use after heart surgery

NCT ID NCT07671469

Disease control Sponsor: Yan Mia Min Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study compares two ways of deciding when heart surgery patients need a blood transfusion in the ICU. One uses a fixed blood count threshold, while the other also considers each patient's oxygen and lactate levels. The goal is to see if the personalized approach is as safe and reduces blood use. 900 adults at moderate-to-high surgical risk will participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Personalized transfusion decision rule (a bedside tool using patient oxygen and lactate levels)
What this could lead to: If it works, this could lead to safer, more efficient blood use after heart surgery, reducing unnecessary transfusions while maintaining patient safety.
What could go wrong: This trial hasn't started yet, and the personalized approach may not prove as safe as the standard one. It's a comparison of existing strategies, not a new treatment.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia Blood transfusion Cardiac surgery Cardiopulmonary bypass

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Smarter transfusions: tailoring blood use after heart surgery

What the study statuses mean