Personalized Blood Transfusion Protocol for Cardiac Patients

N/ANot Yet RecruitingNCT07671469

Yan Mia Min900 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

900

Conditions

Cardiac Surgery Blood Transfusion Anemia Cardiopulmonary Bypass

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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 longer

Secondary Outcomes

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 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Through 28 days postoperatively

Number of participants with a postoperative infection

Time frame: Through 28 days postoperatively

Duration of intensive care unit stay

Time frame: From ICU admission to ICU discharge, up to 28 days

Duration of hospital stay

Time frame: From surgery to hospital discharge, an average of up to 28 days

Personalized Blood Transfusion Protocol for Cardiac Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts