An observational study in Cardiac Surgical Procedures, Blood Transfusion and Anemia, sponsored by Aveiro University. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Aveiro University · Observational
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:
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.
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 657 is above the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →Aveiro University is the lead sponsor of 59 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults undergoing elective on-pump cardiac surgery at Unidade Local de Saúde Gaia/Espinho, Portugal, between January 2023 and December 2027.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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).
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.
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.
Also known as: Cell salvage, Autologous blood salvage, Autotransfusion
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.
Time frame: From the day of surgery through hospital discharge, an average of 6 days
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
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
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.
Time frame: During surgery
Cell salvage volumes
Anticoagulant solution prepared and aspirated, and blood collected, processed and reinfused per episode (mL).
Time frame: During surgery
Cell salvage consumables
Use of collection set only, or collection and processing sets, per procedure.
Time frame: 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.
Time frame: During surgery
Re-exploration for bleeding or cardiac tamponade
Unplanned return to the operating theatre for bleeding or cardiac tamponade.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the day of surgery through hospital discharge, an average of 6 days
New-onset postoperative atrial fibrillation
New-onset atrial fibrillation after surgery.
Time frame: From the day of surgery through hospital discharge, an average of 6 days
Surgical site infection or mediastinitis
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
Length of stay in the intensive care unit (days), including any readmission to the intensive care unit.
Time frame: 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.
Time frame: 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.
Time frame: From the day of surgery through hospital discharge, an average of 6 days
12-month survival
Survival at 12 months after surgery.
Time frame: 12 months after surgery
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jan 2028, 13 months later.
Of 124 non-industry observational studies under Anemia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 13 months is below that.
Counting every sponsor, half of 145 studies reached it within 30 months; a quarter within 12 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Aveiro University