Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme (SPARE)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Sandrine Jorge, MSc
- 전화번호: 41352 +351 227865100
- 이메일: sandrine.jorge@ulsge.min-saude.pt
연구 장소
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Porto District
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Vila Nova de Gaia, Porto District, 포르투갈, 4434-502
- Unidade Local de Saúde Gaia/Espinho
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연락하다:
- Sandrine Jorge, MSc
- 전화번호: 41352 +351 227865100
- 이메일: sandrine.jorge@ulsge.min-saude.pt
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adults undergoing elective on-pump cardiac surgery at Unidade Local de Saúde Gaia/Espinho, Portugal, between January 2023 and December 2027.
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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. |
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.
다른 이름들:
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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). |
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants receiving allogeneic red blood cell transfusion
기간: From the day of surgery through hospital discharge, an average of 6 days
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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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants receiving allogeneic blood products and haemostatic concentrates
기간: From the day of surgery through hospital discharge, an average of 6 days
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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
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Number of allogeneic blood product units per participant
기간: From the day of surgery through hospital discharge, an average of 6 days
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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
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Fibrinogen concentrate dose per participant
기간: From the day of surgery through hospital discharge, an average of 6 days
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Total fibrinogen concentrate administered per participant (g). |
From the day of surgery through hospital discharge, an average of 6 days
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Four-factor prothrombin complex concentrate dose per participant
기간: From the day of surgery through hospital discharge, an average of 6 days
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Total four-factor prothrombin complex concentrate administered per participant (IU). |
From the day of surgery through hospital discharge, an average of 6 days
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Perioperative haemoglobin trajectory
기간: 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)
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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)
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SPARE protocol adherence
기간: During surgery
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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
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Cell salvage volumes
기간: During surgery
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Anticoagulant solution prepared and aspirated, and blood collected, processed and reinfused per episode (mL). |
During surgery
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Cell salvage consumables
기간: During surgery
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Use of collection set only, or collection and processing sets, per procedure. |
During surgery
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Reasons for cell salvage non-use in Group C
기간: During surgery
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Categorised as professional practice variation without a documented clinical reason, other documented reason, or not recorded. |
During surgery
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Re-exploration for bleeding or cardiac tamponade
기간: From the day of surgery through hospital discharge, an average of 6 days
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Unplanned return to the operating theatre for bleeding or cardiac tamponade. |
From the day of surgery through hospital discharge, an average of 6 days
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Other unplanned surgical reinterventions
기간: From the day of surgery through hospital discharge, an average of 6 days
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Unplanned surgical reinterventions other than re-exploration for bleeding. |
From the day of surgery through hospital discharge, an average of 6 days
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Acute kidney injury
기간: From the day of surgery through hospital discharge, an average of 6 days
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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
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New-onset stroke or transient ischaemic attack
기간: Up to hospital discharge or 30 days after surgery, whichever is later
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New-onset stroke or transient ischaemic attack. |
Up to hospital discharge or 30 days after surgery, whichever is later
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Perioperative myocardial infarction
기간: From the day of surgery through hospital discharge, an average of 6 days
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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
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New-onset postoperative atrial fibrillation
기간: From the day of surgery through hospital discharge, an average of 6 days
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New-onset atrial fibrillation after surgery. |
From the day of surgery through hospital discharge, an average of 6 days
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Surgical site infection or mediastinitis
기간: From the day of surgery through hospital discharge, an average of 6 days
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Surgical site infection or mediastinitis. |
From the day of surgery through hospital discharge, an average of 6 days
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Intensive care unit length of stay
기간: 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
|
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Hospital length of stay
기간: 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
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In-hospital mortality
기간: From the day of surgery through hospital discharge, an average of 6 days
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Death from any cause during the index hospital stay. |
From the day of surgery through hospital discharge, an average of 6 days
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12-month survival
기간: 12 months after surgery
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Survival at 12 months after surgery. |
12 months after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sandrine Jorge, MSc, Unidade Local de Saúde Gaia/Espinho
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 45-CE-ICVS/CAC-EMHA/24.09.2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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