Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme (SPARE)

2 de novembro de 2026 atualizado por: Sandrine Jorge, Aveiro University

Systematic Perioperative Autologous-Blood Salvage to Reduce Allogeneic Transfusion Exposure in On-Pump Cardiac Surgery: A Quasi-Experimental Study (SPARE)

The goal of this observational study is to learn if cell salvage lowers the need for donor blood in adults having planned heart surgery with a heart-lung machine. Cell salvage collects the blood a person loses during surgery, cleans it and gives it back to them. The hospital already has a programme to lower blood loss and the need for donor blood. Since January 2025, it uses cell salvage in all eligible people.

The main question it aims to answer is:

- Do fewer participants need donor red blood cells during their hospital stay when cell salvage is used in everyone?

Researchers will compare people who had surgery with cell salvage from January 2025 to:

  • people who had surgery in 2023 and 2024, before this change
  • people who had surgery from January 2025 without cell salvage

to see if fewer of them need donor blood.

Researchers will also look at the use of other blood products, red blood cell levels, complications, time in hospital, and survival 12 months after surgery.

Participants will have their usual surgery and care. The study does not change their treatment. Researchers will collect information from their medical records, from surgery up to 12 months later.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Background: Intraoperative cell salvage (ICS) is a patient blood management (PBM) strategy with guideline recommendations in cardiac surgery with cardiopulmonary bypass (CPB). Evidence on its effectiveness remains inconsistent, and its incremental contribution has rarely been evaluated separately from broader PBM implementation.

Setting: Unidade Local de Saúde Gaia/Espinho (ULSGE), Portugal, where a structured PBM programme in cardiac surgery has been in place since January 2019 and reached full multimodal maturity by approximately October 2022. Systematic ICS (the SPARE protocol) was introduced in January 2025; apart from this, no other institutional PBM protocol, including transfusion thresholds, changed between 2023 and the study period.

Design: Observational cohort study with a quasi-experimental design (one intervention group and two control groups). ICS is delivered as institutional standard of care and is not assigned by the investigators. Group A (systematic ICS, from January 2025) is compared with Group B (historical control, 2023-2024; alpha comparison) and with Group C (contemporaneous eligible patients who did not receive ICS; beta comparison).

Data collection: Data will be collected retrospectively from electronic health records for Group B and for patients in Groups A and C operated on before ethics approval (20 October 2026), under a waiver of consent granted by the Ethics Committee, and prospectively thereafter, with written informed consent. Inclusion of Groups A and C will continue until December 2027, with follow-up until December 2028. Data will be stored in pseudonymised form.

PBM exposure: A patient-level PBM Exposure Score (PBM-ES; preoperative haemoglobin optimisation, prophylactic tranexamic acid, reduced-prime CPB strategy, viscoelastic test-guided coagulation management) will be used as a covariate in a pre-planned sensitivity analysis and in pre-specified subgroup analyses.

Sample size: Assuming allogeneic red blood cell transfusion rates of 18% in Group A and 29.7% in the comparator groups (two-sided alpha 5%, power 80%), 208 patients per group are required; inflated by 5% for missing data, the minimum is 219 per group (657 in total).

Statistical analysis: Chi-squared or Fisher's exact tests with prevalence ratios and 95% confidence intervals; multivariable logistic regression for the primary outcome and linear regression for continuous outcomes, adjusted for pre-specified confounders; repeated-measures analysis for haemoglobin trajectory; pre-specified subgroup analyses.

Tipo de estudo

Observacional

Inscrição (Estimado)

657

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

Locais de estudo

  • Portugal
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Adults undergoing elective on-pump cardiac surgery at Unidade Local de Saúde Gaia/Espinho, Portugal, between January 2023 and December 2027.

Descrição

Inclusion Criteria:

  • Adults aged 18 years or older
  • Elective on-pump cardiac surgery at Unidade Local de Saúde Gaia/Espinho, including isolated or combined coronary artery bypass grafting, valve and aortic procedures
  • Surgery performed within the defined period for each group (Group B: January 2023 to December 2024; Groups A and C: January 2025 to December 2027)

Exclusion Criteria:

  • Emergency or urgent procedures
  • Off-pump procedures
  • Patients who declined allogeneic blood transfusion (eg, Jehovah's Witnesses)
  • Pregnant or lactating patients
  • Known haematological malignancy, active or under treatment
  • Diagnosed inherited coagulopathy requiring specialist haematology follow-up (eg, haemophilia, inherited von Willebrand disease)

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

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: OTHER

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Group A - Systematic ICS (SPARE protocol)

Adults undergoing elective on-pump cardiac surgery from January 2025 in whom intraoperative cell salvage is used systematically, as institutional standard of care, within a mature patient blood management programme.
Procedimento: Systematic intraoperative cell salvage

Intraoperative collection, centrifugation and washing of shed blood, with processing and reinfusion of residual cardiopulmonary bypass circuit blood at the end of the procedure, applied as institutional standard of care to all eligible procedures irrespective of anticipated blood loss or procedural complexity. Not assigned by the investigators.

Outros nomes:
  • Cell salvage
  • Autologous blood salvage
  • Autotransfusion
Group B - Historical control

All eligible adults who underwent elective on-pump cardiac surgery between January 2023 and December 2024, within the same mature patient blood management programme, when intraoperative cell salvage followed the previous selective policy (included irrespective of whether it was used).
Group C - Contemporaneous control

Eligible adults undergoing elective on-pump cardiac surgery in the same period as Group A who did not receive intraoperative cell salvage, reflecting professional practice variation without a documented clinical reason.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of participants receiving allogeneic red blood cell transfusion
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Proportion of participants receiving at least one unit of allogeneic red blood cells, compared between Group A and Group B and between Group A and Group C.
From the day of surgery through hospital discharge, an average of 6 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of participants receiving allogeneic blood products and haemostatic concentrates
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Proportion of participants receiving red blood cells, fresh frozen plasma, platelets, fibrinogen concentrate and four-factor prothrombin complex concentrate, reported separately for each product.
From the day of surgery through hospital discharge, an average of 6 days
Number of allogeneic blood product units per participant
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Number of red blood cell, fresh frozen plasma and platelet units transfused per participant, reported separately for each product.
From the day of surgery through hospital discharge, an average of 6 days
Fibrinogen concentrate dose per participant
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Total fibrinogen concentrate administered per participant (g).
From the day of surgery through hospital discharge, an average of 6 days
Four-factor prothrombin complex concentrate dose per participant
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Total four-factor prothrombin complex concentrate administered per participant (IU).
From the day of surgery through hospital discharge, an average of 6 days
Perioperative haemoglobin trajectory
Prazo: Before and during cardiopulmonary bypass, after cell salvage reinfusion or protamine administration, at the postoperative nadir, and at hospital discharge (an average of 6 days after surgery)

Haemoglobin (g/dL) at five pre-specified time points: first intraoperative reading before cardiopulmonary bypass; intraoperative nadir on cardiopulmonary bypass; after cell salvage reinfusion (or after protamine in participants without reinfusion); postoperative nadir; hospital discharge.
Before and during cardiopulmonary bypass, after cell salvage reinfusion or protamine administration, at the postoperative nadir, and at hospital discharge (an average of 6 days after surgery)
SPARE protocol adherence
Prazo: During surgery

Proportion of eligible procedures performed from January 2025 (Groups A and C combined) in which salvaged blood was processed and reinfused (target 95% or more); procedures with collection only are reported as protocol deviations.
During surgery
Cell salvage volumes
Prazo: During surgery

Anticoagulant solution prepared and aspirated, and blood collected, processed and reinfused per episode (mL).
During surgery
Cell salvage consumables
Prazo: During surgery

Use of collection set only, or collection and processing sets, per procedure.
During surgery
Reasons for cell salvage non-use in Group C
Prazo: During surgery

Categorised as professional practice variation without a documented clinical reason, other documented reason, or not recorded.
During surgery
Re-exploration for bleeding or cardiac tamponade
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Unplanned return to the operating theatre for bleeding or cardiac tamponade.
From the day of surgery through hospital discharge, an average of 6 days
Other unplanned surgical reinterventions
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Unplanned surgical reinterventions other than re-exploration for bleeding.
From the day of surgery through hospital discharge, an average of 6 days
Acute kidney injury
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Acute kidney injury according to KDIGO 2012 criteria, stages 1 to 3.
From the day of surgery through hospital discharge, an average of 6 days
New-onset stroke or transient ischaemic attack
Prazo: Up to hospital discharge or 30 days after surgery, whichever is later

New-onset stroke or transient ischaemic attack.
Up to hospital discharge or 30 days after surgery, whichever is later
Perioperative myocardial infarction
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Perioperative myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction.
From the day of surgery through hospital discharge, an average of 6 days
New-onset postoperative atrial fibrillation
Prazo: From the day of surgery through hospital discharge, an average of 6 days

New-onset atrial fibrillation after surgery.
From the day of surgery through hospital discharge, an average of 6 days
Surgical site infection or mediastinitis
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Surgical site infection or mediastinitis.
From the day of surgery through hospital discharge, an average of 6 days
Intensive care unit length of stay
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Length of stay in the intensive care unit (days), including any readmission to the intensive care unit.
From the day of surgery through hospital discharge, an average of 6 days
Hospital length of stay
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Days from the day of surgery to hospital discharge.
From the day of surgery through hospital discharge, an average of 6 days
In-hospital mortality
Prazo: From the day of surgery through hospital discharge, an average of 6 days

Death from any cause during the index hospital stay.
From the day of surgery through hospital discharge, an average of 6 days
12-month survival
Prazo: 12 months after surgery

Survival at 12 months after surgery.
12 months after surgery

Colaboradores e Investigadores

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

Patrocinador

Aveiro University

Colaboradores

Unidade Local de Saúde Gaia/Espinho

Investigadores

  • Investigador principal: Sandrine Jorge, MSc, Unidade Local de Saúde Gaia/Espinho

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 dezembro de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

28 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de novembro de 2026

Primeira postagem (Real)

6 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 45-CE-ICVS/CAC-EMHA/24.09.2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared, in accordance with the data protection impact assessment approved for this study. Aggregate results will be published in peer-reviewed journals.

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 .

Se inscrever