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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia; Postoperative Hemorrhage; Blood Transfusion; Cardiac Surgical Procedures
• Intervention / Treatment: Procedure: Systematic intraoperative cell salvage

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 657

Contacts and Locations

• Study Contact: Name: Sandrine Jorge, MSc; Phone Number: 41352 +351 227865100; Email: sandrine.jorge@ulsge.min-saude.pt

Study Locations

• Portugal
  • Porto District
    • Vila Nova de Gaia, Porto District, Portugal, 4434-502
      • Unidade Local de Saúde Gaia/Espinho
      • Contact: Sandrine Jorge, MSc; Phone Number: 41352 +351 227865100; Email: sandrine.jorge@ulsge.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: OTHER

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants receiving allogeneic red blood cell transfusion	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants receiving allogeneic blood products and haemostatic concentrates	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	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	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	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	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	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	Anticoagulant solution prepared and aspirated, and blood collected, processed and reinfused per episode (mL).	During surgery
Cell salvage consumables	Use of collection set only, or collection and processing sets, per procedure.	During surgery
Reasons for cell salvage non-use in Group C	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	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	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	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	New-onset stroke or transient ischaemic attack.	Up to hospital discharge or 30 days after surgery, whichever is later
Perioperative myocardial infarction	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	New-onset atrial fibrillation after surgery.	From the day of surgery through hospital discharge, an average of 6 days
Surgical site infection or mediastinitis	Surgical site infection or mediastinitis.	From the day of surgery through hospital discharge, an average of 6 days
Intensive care unit length of stay	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	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	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	Survival at 12 months after surgery.	12 months after surgery

Collaborators and Investigators

• Sponsor: Aveiro University
• Collaborators: Unidade Local de Saúde Gaia/Espinho
• Investigators: Principal Investigator: Sandrine Jorge, MSc, Unidade Local de Saúde Gaia/Espinho

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 28, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Cardiopulmonary bypass; Patient blood management; Quasi-experimental study; Intraoperative cell salvage; Allogeneic transfusion
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Hemorrhage; Hematologic Diseases; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Anemia; Postoperative Hemorrhage; Therapeutics; Surgical Procedures, Operative; Transplantation; Biological Therapy; Blood Transfusion; Tissue and Organ Harvesting; Operative Blood Salvage; Blood Transfusion, Autologous
• Other Study ID Numbers: 45-CE-ICVS/CAC-EMHA/24.09.2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No