Personalized Blood Transfusion Protocol for Cardiac Patients (PerP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia; Cardiac Surgery; Cardiopulmonary Bypass; Blood Transfusion
• Intervention / Treatment: Other: Demand-Informed Transfusion Decision Rule

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Min, MD, PhD; Phone Number: 650-666-9504; Email: yanmin@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Restrictive Threshold (Control); 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; 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.; Other Names: Personalized transfusion strategy
Experimental: Demand-Informed (Personalized) Strategy (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; 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.; Other Names: Personalized transfusion strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months after surgery
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.	In-hospital for the index procedure or within 28 days of surgery, whichever is longer
Number of participants with postoperative myocardial infarction	Per the Fourth Universal Definition (Type 5, CABG-related).	In-hospital or within 28 days of surgery, whichever is longer
Number of participants with postoperative stroke	New central focal neurological deficit confirmed by CT or MRI.	In-hospital or within 28 days of surgery, whichever is longer
Number of participants with new renal failure requiring dialysis	KDIGO Stage 3 AKI with initiation of renal replacement therapy, in patients not on chronic dialysis preoperatively.	In-hospital or within 28 days of surgery, whichever is longer
Number of participants with postoperative acute kidney injury	AKI defined by KDIGO criteria (any stage).	Through 28 days postoperatively
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

Collaborators and Investigators

• Sponsor: Yan Mia Min
• Collaborators: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): October 19, 2029
• Study Completion (Estimated): March 15, 2030

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; ICU; oxygen delivery; restrictive transfusion; hemoglobin trhreshold
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia
• Other Study ID Numbers: 84310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No