Personalized Blood Transfusion Protocol for Cardiac Patients (PerP)
26 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
900
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yan Min, MD, PhD
- Número de telefone: 650-666-9504
- E-mail: yanmin@stanford.edu
Locais de estudo
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California
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Palo Alto, California, Estados Unidos, 94305
- Stanford University Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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.
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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.
Outros nomes:
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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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants with the composite of all-cause mortality, myocardial infarction, stroke, or new renal failure requiring dialysis
Prazo: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants who die from any cause by 6 months after surgery
Prazo: 6 months after surgery
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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).
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6 months after surgery
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Number of participants who die (all-cause surgical mortality)
Prazo: In-hospital for the index procedure or within 28 days of surgery, whichever is longer
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Death from any cause occurring in-hospital during the index-procedure admission or within 28 days of surgery, whichever is longer.
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In-hospital for the index procedure or within 28 days of surgery, whichever is longer
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Number of participants with postoperative myocardial infarction
Prazo: In-hospital or within 28 days of surgery, whichever is longer
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Per the Fourth Universal Definition (Type 5, CABG-related).
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In-hospital or within 28 days of surgery, whichever is longer
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Number of participants with postoperative stroke
Prazo: In-hospital or within 28 days of surgery, whichever is longer
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New central focal neurological deficit confirmed by CT or MRI.
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In-hospital or within 28 days of surgery, whichever is longer
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Number of participants with new renal failure requiring dialysis
Prazo: In-hospital or within 28 days of surgery, whichever is longer
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KDIGO Stage 3 AKI with initiation of renal replacement therapy, in patients not on chronic dialysis preoperatively.
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In-hospital or within 28 days of surgery, whichever is longer
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Number of participants with postoperative acute kidney injury
Prazo: Through 28 days postoperatively
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AKI defined by KDIGO criteria (any stage).
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Through 28 days postoperatively
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Number of participants with a postoperative infection
Prazo: Through 28 days postoperatively
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Through 28 days postoperatively
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Duration of intensive care unit stay
Prazo: From ICU admission to ICU discharge, up to 28 days
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From ICU admission to ICU discharge, up to 28 days
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Duration of hospital stay
Prazo: From surgery to hospital discharge, an average of up to 28 days
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From surgery to hospital discharge, an average of up to 28 days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
14 de setembro de 2026
Conclusão Primária (Estimado)
19 de outubro de 2029
Conclusão do estudo (Estimado)
15 de março de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
22 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de junho de 2026
Primeira postagem (Real)
26 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 84310
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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