Personalized Blood Transfusion Protocol for Cardiac Patients

NCT07671469 | Not Yet Recruiting DMC

• 1 other identifier: 84310
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Blood Transfusion; Anemia; Cardiopulmonary Bypass

Keywords

restrictive transfusion; hemoglobin trhreshold; oxygen delivery; cardiac surgery; ICU

Outcome Measures

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.

  In-hospital for the index procedure or within 28 days of surgery, whichever is longer

Secondary Outcomes (9)

• Number of participants who die from any cause by 6 months after surgery

  6 months after surgery

• Number of participants who die (all-cause surgical mortality)

  In-hospital for the index procedure 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

• Number of participants with postoperative stroke

  In-hospital or within 28 days of surgery, whichever is longer

• Number of participants with new renal failure requiring dialysis

  In-hospital or within 28 days of surgery, whichever is longer

Study Arms (2)

Standard Restrictive Threshold (Control)

ACTIVE COMPARATOR

Beginning on arrival to the cardiac ICU after surgery, transfusion of red blood cells is generally recommended when hemoglobin is below 7.5 g/dL, consistent with current institutional practice and major restrictive-threshold trials. Standard surgical, anesthesia, perfusion, monitoring, and postoperative care are provided to all participants.

Other: Demand-Informed Transfusion Decision Rule

Demand-Informed (Personalized) Strategy (Experimental)

EXPERIMENTAL

Beginning on arrival to the cardiac ICU, an absolute safety floor recommends transfusion when hemoglobin is below 7.0 g/dL regardless of physiology. Between 7.0 and 7.5 g/dL, transfusion decisions are guided by predefined physiologic markers of oxygen balance (e.g., indexed oxygen delivery, venous oxygen saturation, lactate trends): transfusion may be deferred when markers indicate adequate oxygen delivery and is recommended when markers indicate compromised delivery. At or above 7.5 g/dL the rule does not recommend transfusion. The rule is advisory; clinicians may override at any time, and overrides are recorded.

Other: Demand-Informed Transfusion Decision Rule

Interventions

Demand-Informed Transfusion Decision Rule OTHER

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.

Also known as: Personalized transfusion strategy

Demand-Informed (Personalized) Strategy (Experimental); Standard Restrictive Threshold (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yan Mia Min: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yan Min, MD, PhD

CONTACT

650-666-9504; yanmin@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Protocol Director

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): October 19, 2029
• Study Completion (Estimated): March 15, 2030
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)