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Personalized Blood Transfusion Protocol for Cardiac Patients (PerP)

26. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

900

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Palo Alto, California, Forente stater, 94305
        • Stanford University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv 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.
Annen: 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.
Andre navn:
  • Personalized transfusion strategy
Eksperimentell: 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.
Annen: 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.
Andre navn:
  • Personalized transfusion strategy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants who die from any cause by 6 months after surgery
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Through 28 days postoperatively
AKI defined by KDIGO criteria (any stage).
Through 28 days postoperatively
Number of participants with a postoperative infection
Tidsramme: Through 28 days postoperatively
Through 28 days postoperatively
Duration of intensive care unit stay
Tidsramme: From ICU admission to ICU discharge, up to 28 days
From ICU admission to ICU discharge, up to 28 days
Duration of hospital stay
Tidsramme: From surgery to hospital discharge, an average of up to 28 days
From surgery to hospital discharge, an average of up to 28 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yan Mia Min

Samarbeidspartnere

Stanford University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

14. september 2026

Primær fullføring (Antatt)

19. oktober 2029

Studiet fullført (Antatt)

15. mars 2030

Datoer for studieregistrering

Først innsendt

22. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 84310

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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