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Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project

1 de junho de 2026 atualizado por: Dr. Glenio Mizubuti (MD, PhD, FRCPC)

Reducing Red Blood Cell Transfusion Requirements for Hepatectomy - A Quality Improvement Project

The goal of this clinical trial is to determine if implementing a controlled blood removal protocol (i.e. hypovolemic phlebotomy [HP] where approximately 10% of the patient's blood is removed and reinfused following hepatic resection as described in the PRICE-2 clinical trial) will reduce the rate of blood transfusions in liver resection surgery at Kingston Health Sciences Centre. Our goals (not included in the PRICE-2 trial) are as follows:

  • Improved monitoring of how the body responds during surgery following controlled blood removal. We will conduct blood tests to look at oxygen, carbon dioxide, lactate, and acid (pH) levels in the blood as well as urine output.
  • Standardized guidelines for how fluids and blood pressure medications are used during surgery to reduce blood loss and keep hemodynamics stable.
  • Monitor patients' recovery following surgery to track complications, injury to the heart, length of hospital stay, and outcomes for up to 90 days. We will also compare long-term recurrence rate of liver cancer compared to patients in the past at our site who did not receive the controlled blood removal (i.e., HP) prior to surgery.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

60

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

Estude backup de contato

  • Nome: Anthony M. H. Ho, MD, MSc, FRCPC
  • Número de telefone: (613) 548-7827
  • E-mail: hoamh@hotmail.com

Locais de estudo

  • Canadá
    • Ontario
      • Kingston, Ontario, Canadá, K7L 2V7
        • Kingston Health Sciences Centre
        • Contato:
        • Contato:
        • Subinvestigador:
          • Sean Bennett, MD, MSc, FRCSC, FACS
        • Subinvestigador:
          • Rachel Phelan, MSc
        • Subinvestigador:
          • Jeannie Callum, MD, FRCSC
        • Subinvestigador:
          • Jennifer Fleming, MD, FRCSC, MAS
        • Subinvestigador:
          • Christopher Haley, MD, FRCSC, MScHQ
        • Subinvestigador:
          • Jordan Leitch, MD, FRCSC, MSc
        • Subinvestigador:
          • Sulaiman Nanji, MD, FRCSC
        • Subinvestigador:
          • Emma Renard, MD, FRCSC
        • Subinvestigador:
          • Steve Tresierra, MD, FRCSC
        • Subinvestigador:
          • Anne Cao, BMsc

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

Método de amostragem

Amostra Não Probabilística

População do estudo

Adults aged ≥18 years undergoing elective hepatic resection at Kingston Health Sciences Centre.

Descrição

Inclusion Criteria:

  • Liver resection in this study is defined according to the PRICE-2 trial, involving 3 or more liver segments, such as right posterior sectionectomy (of segments VI and VII) as well as central resections involving segments IVb and V, along with expected blood loss of >250 mL
  • in patients with known liver cirrhosis, resection of a full segment was included.

Exclusion Criteria (defined according to the PRICE-2 trial):

  • current cardiac condition (e.g., MI within the last 6 months, hypertrophic cardiomyopathy, severe valvular disease, or other unstable coronary syndromes)
  • history of cerebrovascular disease (CVA within the past 6 months or severe carotid stenosis with more than 70% occlusion)
  • history of significant peripheral vascular disease (not yet revascularized with regular/ongoing claudication)
  • A current pregnancy
  • A documented, patient-declared refusal to undergo phlebotomy and transfusion
  • preoperative autologous blood donation
  • presence of active infection
  • preoperative hemoglobin <100 g/L
  • GFR <60 mL/min
  • platelets count <100 × 109/L
  • Uncorrectable coagulopathies or other decompensated cardiac or respiratory conditions that would contraindicate acute volume depletion
  • undergoing emergency surgery
  • planned intraoperative use of cell salvage
  • inability to participate in follow up
  • in the case of repeat liver resections, previous participation in the trial

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

Coortes e Intervenções

Grupo / Coorte
Standardized hypovolemic phlebotomy protocol
Adult patients at KHSC who are undergoing elective liver resection will receive hypovolemic phlebotomy (HP) in addition to standard anesthetic and surgical care. Following induction of general anesthesia and before hepatic resection, 10% of estimated total blood volume (approximately 7-10 mL/kg) will be removed via central venous access or a large bore peripheral venous line. Hemodynamic changes following phlebotomy will be managed using vasopressors [phenylephrine +/- norepinephrine at the discretion of the attending anesthesiologist(s)] instead of routine IV crystalloid replacement. The goal is to maintain mean arterial pressure ≥65 mmHg. Serial physiologic monitoring will include arterial blood gases, lactate levels, urine output, and hemodynamic parameters at predefined timepoints (pre-phlebotomy after induction, post-phlebotomy, end of resection and in PACU). Autologous blood will be reinfused as needed if bleeding occurs prior to surgical closure (within 8 hours of collection).
Historical comparator cohort
A retrospective chart review will be conducted to assess the outcomes of previous elective liver resections prior to the introduction of hypovolemic phlebotomy at KHSC. This population will serve as a control cohort for our prospective data to document a structured hypovolemic phlebotomy approach that leads to measurable improvements in intraoperative management and perioperative outcomes. Data extracted will include demographics, indication for resection, baseline risk factors, operative variables (type and extent of resection, estimated blood loss, total fluid administered, vasopressor use including agent, dose, duration and any intraoperative transfusions of blood products). Postoperative outcomes will also be collected, including hemoglobin levels, total length of hospital stay, ICU admission (if applicable), total intraoperative blood product usage, 30- and 90- day mortality, and post-operative complications. The same exclusion criteria as the intervention group will be applied.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Reduction of intraoperative red blood cell (RBC) transfusion rates.
Prazo: Perioperatively, from hospital admission to discharge.
To change intraoperative transfusion rates (representing a 38% reduction based on PRICE-2 trial) in elective hepatectomies for cancer at KHSC upon implementation of a standardized hypovolemic phlebotomy protocol. In so doing, we aim to make our local transfusion rate in line with the average transfusion rate across centers in Ontario, Canada.
Perioperatively, from hospital admission to discharge.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Rate of change in pH based on serial arterial blood gases during hepatectomy.
Prazo: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Intraoperative assessment of changes in pH based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Rate of change in PaO2 and PaCO2 (mmHg) based on serial arterial blood gases during hepatectomy.
Prazo: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Intraoperative assessment of changes in PaO2 and PaCO2 (mmHg) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Rate of change in serum lactate (mmol/L) based on serial arterial blood gases during hepatectomy.
Prazo: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Intraoperative assessment of changes in lactate (mmol/L) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Rate of change in urine output (mL) during hepatectomy.
Prazo: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Intraoperative assessment of changes in urine output (mL) relative to the volume of blood removed during hepatectomy.
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Total dose of vasopressors (ephedrine, phenylephrine, norepinephrine, epinephrine, vasopressin) required to maintain a mean arterial pressure (MAP) target of ≥65 mmHg intraoperatively during hypovolemic phlebotomy hepatectomy.
Prazo: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Track total dose (mg/mcg/units) of vasopressors (ephedrine, phenylephrine, norepinephrine, epinephrine, vasopressin) required intraoperatively to maintain a target MAP ≥65 mmHg during hypovolemic phlebotomy hepatectomy.
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Incidence of in-hospital postoperative complications following hypovolemic phlebotomy.
Prazo: Perioperatively, from completion of surgery to hospital discharge.
Track postoperative (e.g., cardiovascular, respiratory, neurologic, renal, etc.) complications during hospital stay following hepatectomy.
Perioperatively, from completion of surgery to hospital discharge.
Incidence of morbimortality at 90 days and 5 years following hypovolemic phlebotomy hepatectomy.
Prazo: Postoperatively, from completion of surgery to 5 years post-operation.
Track postoperative (cardiovascular, respiratory, neurologic, renal, etc.) complications as well as cancer recurrence at 90-day and 5-year postoperatively. Long-term (5-year) liver cancer recurrence will be compared to a historical local cohort as control. Measurement will be performed by phone call by research personnel.
Postoperatively, from completion of surgery to 5 years post-operation.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Dr. Glenio Mizubuti (MD, PhD, FRCPC)

Investigadores

  • Investigador principal: Glenio Mizubuti, MD, PhD, FRCPC, Kingston Health Sciences Centre

Publicações e links úteis

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Publicações Gerais

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)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2028

Conclusão do estudo (Estimado)

1 de junho de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

5 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 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

  • 6045703

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

We will not be sharing individual participant data as it will be aggregated and deidentified.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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