Cardiac Surgical ProceduresSPARENCT07922486
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
An observational study of Cardiac Surgical Procedures and Blood Transfusion, run by Aveiro University at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Blood Transfusion, Anemia
- What is being tested?
- Systematic intraoperative cell salvage
- Type of treatment
- Surgery or procedure
- How many people
- 657 participants
- Where
- 1 sitePortugal
- Study dates
- Dec 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing elective on-pump cardiac surgery at Unidade Local de Saúde Gaia/Espinho, Portugal, between January 2023 and December 2027.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Unidade Local de Saúde Gaia/Espinho
Vila Nova de Gaia, Porto District, 4434-502
Sandrine Jorge, MSc, +351 227865100 ext. 41352, sandrine.jorge@ulsge.min-saude.pt
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Being tested
- Systematic intraoperative cell salvage
- Keywords
- Intraoperative cell salvage, Patient blood management, Cardiopulmonary bypass, Allogeneic transfusion, Quasi-experimental study
- Medical subject headings
- Anemia, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic intraoperative cell salvageProcedure or surgery
Also called Cell salvage, Autologous blood salvage, Autotransfusion
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Systematic intraoperative cell salvage | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of surgery through hospital discharge, an average of 6 days
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: During surgery
Cell salvage volumes
Anticoagulant solution prepared and aspirated, and blood collected, processed and reinfused per episode (mL).
Measured: During surgery
Cell salvage consumables
Use of collection set only, or collection and processing sets, per procedure.
Measured: 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.
Measured: During surgery
Re-exploration for bleeding or cardiac tamponade
Unplanned return to the operating theatre for bleeding or cardiac tamponade.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the day of surgery through hospital discharge, an average of 6 days
New-onset postoperative atrial fibrillation
New-onset atrial fibrillation after surgery.
Measured: From the day of surgery through hospital discharge, an average of 6 days
Surgical site infection or mediastinitis
Surgical site infection or mediastinitis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the day of surgery through hospital discharge, an average of 6 days
12-month survival
Survival at 12 months after surgery.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 657 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde Gaia/Espinho
- Responsible party
- Principal investigator, Sandrine Jorge, Aveiro University
- Investigators
- Sandrine Jorge, MSc, Principal investigator, Unidade Local de Saúde Gaia/Espinho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922486
- Sponsor's protocol ID
- 45-CE-ICVS/CAC-EMHA/24.09.2026
- Acronym
- SPARE
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Perioperative Autologous-Blood Salvage to Reduce Allogeneic Transfusion Exposure in On-Pump Cardiac Surgery: A Quasi-Experimental Study (SPARE)
- ClinicalTrials.gov ID
- NCT07922486
- Acronym / sponsor ID
- SPARE / 45-CE-ICVS/CAC-EMHA/24.09.2026
- Keywords
- Intraoperative cell salvage, Patient blood management, Cardiopulmonary bypass, Allogeneic transfusion, Quasi-experimental study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 657 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde Gaia/Espinho
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Systematic ICS (SPARE protocol) | – | Procedure: Systematic intraoperative cell salvageAdults 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing elective on-pump cardiac surgery at Unidade Local de Saúde Gaia/Espinho, Portugal, between January 2023 and December 2027.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic intraoperative cell salvageAlso: Cell salvage, Autologous blood salvage, AutotransfusionIntraoperative 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. | Procedure or surgery | Group A - Systematic ICS (SPARE protocol) |
Primary outcome
Proportion of participants receiving allogeneic red blood cell transfusion
Time frame: 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.
20 secondary outcomes
Proportion of participants receiving allogeneic blood products and haemostatic concentrates
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Number of allogeneic blood product units per participant
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Fibrinogen concentrate dose per participant
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Four-factor prothrombin complex concentrate dose per participant
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Perioperative haemoglobin trajectory
Time frame: 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
Time frame: During surgery
Cell salvage volumes
Time frame: During surgery
Cell salvage consumables
Time frame: During surgery
Reasons for cell salvage non-use in Group C
Time frame: During surgery
Re-exploration for bleeding or cardiac tamponade
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Other unplanned surgical reinterventions
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Acute kidney injury
Time frame: From the day of surgery through hospital discharge, an average of 6 days
New-onset stroke or transient ischaemic attack
Time frame: Up to hospital discharge or 30 days after surgery, whichever is later
Perioperative myocardial infarction
Time frame: From the day of surgery through hospital discharge, an average of 6 days
New-onset postoperative atrial fibrillation
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Surgical site infection or mediastinitis
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Intensive care unit length of stay
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Hospital length of stay
Time frame: From the day of surgery through hospital discharge, an average of 6 days
In-hospital mortality
Time frame: From the day of surgery through hospital discharge, an average of 6 days
12-month survival
Time frame: 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandrine Jorge, MSc principal investigator
Unidade Local de Saúde Gaia/Espinho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedures and Blood Transfusion, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine Jorge, MSc (+351 227865100 ext. 41352, sandrine.jorge@ulsge.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants receiving allogeneic red blood cell transfusion (time frame: From the day of surgery through hospital discharge, an average of 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.