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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Sandrine Jorge, MSc
- 電話番号：41352 +351 227865100
- メール：sandrine.jorge@ulsge.min-saude.pt
研究場所
-
-
Porto District
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Vila Nova de Gaia、Porto District、ポルトガル、4434-502
- Unidade Local de Saúde Gaia/Espinho
-
コンタクト：
- Sandrine Jorge, MSc
- 電話番号：41352 +351 227865100
- メール：sandrine.jorge@ulsge.min-saude.pt
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults undergoing elective on-pump cardiac surgery at Unidade Local de Saúde Gaia/Espinho, Portugal, between January 2023 and December 2027.
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：OTHER
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
他の名前：
|
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants receiving allogeneic red blood cell transfusion
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants receiving allogeneic blood products and haemostatic concentrates
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：During surgery
|
Anticoagulant solution prepared and aspirated, and blood collected, processed and reinfused per episode (mL). |
During surgery
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|
Cell salvage consumables
時間枠：During surgery
|
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
時間枠：During surgery
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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New-onset postoperative atrial fibrillation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：12 months after surgery
|
Survival at 12 months after surgery. |
12 months after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sandrine Jorge, MSc、Unidade Local de Saúde Gaia/Espinho
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 45-CE-ICVS/CAC-EMHA/24.09.2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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