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Personalized Blood Transfusion Protocol for Cardiac Patients

NCT07671469 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-06-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-14
Primary Completion
2029-10-19
Completion
2030-03-15

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07671469 on ClinicalTrials.gov