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Personalized Blood Transfusion Protocol for Cardiac Patients (PerP)

26. Juni 2026 aktualisiert von: Yan Mia Min

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

900

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • Palo Alto, California, Vereinigte Staaten, 94305
        • Stanford University Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Sonstiges: 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.
Andere Namen:
  • 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.
Sonstiges: 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.
Andere Namen:
  • Personalized transfusion strategy

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
Zeitfenster: In-hospital for the index procedure or within 28 days of surgery, whichever is longer

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants who die from any cause by 6 months after surgery
Zeitfenster: 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)
Zeitfenster: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
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
Zeitfenster: In-hospital or within 28 days of surgery, whichever is longer
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
Zeitfenster: In-hospital or within 28 days of surgery, whichever is longer
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
Zeitfenster: In-hospital or within 28 days of surgery, whichever is longer
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
Zeitfenster: Through 28 days postoperatively
AKI defined by KDIGO criteria (any stage).
Through 28 days postoperatively
Number of participants with a postoperative infection
Zeitfenster: Through 28 days postoperatively
Through 28 days postoperatively
Duration of intensive care unit stay
Zeitfenster: From ICU admission to ICU discharge, up to 28 days
From ICU admission to ICU discharge, up to 28 days
Duration of hospital stay
Zeitfenster: From surgery to hospital discharge, an average of up to 28 days
From surgery to hospital discharge, an average of up to 28 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Yan Mia Min

Mitarbeiter

Stanford University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

14. September 2026

Primärer Abschluss (Geschätzt)

19. Oktober 2029

Studienabschluss (Geschätzt)

15. März 2030

Studienanmeldedaten

Zuerst eingereicht

22. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

26. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 84310

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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