Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
NCT07922486, Not yet recruiting, Aveiro University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme | ClinicalTrials.gov |
| NCT number | NCT07922486 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 657 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Aveiro University | ClinicalTrials.gov |
| Conditions | Cardiac Surgical Procedures, Blood Transfusion, Anemia, Postoperative Hemorrhage | ClinicalTrials.gov |
| Interventions | Systematic intraoperative cell salvage | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants receiving allogeneic red blood cell transfusion | 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. | ClinicalTrials.gov |
| Secondary | Proportion of participants receiving allogeneic blood products and haemostatic concentrates | 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. | ClinicalTrials.gov |
| Secondary | Number of allogeneic blood product units per participant | 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. | ClinicalTrials.gov |
| Secondary | Fibrinogen concentrate dose per participant | From the day of surgery through hospital discharge, an average of 6 days | Total fibrinogen concentrate administered per participant (g). | ClinicalTrials.gov |
| Secondary | Four-factor prothrombin complex concentrate dose per participant | From the day of surgery through hospital discharge, an average of 6 days | Total four-factor prothrombin complex concentrate administered per participant (IU). | ClinicalTrials.gov |
| Secondary | Perioperative haemoglobin trajectory | 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. | ClinicalTrials.gov |
| Secondary | SPARE protocol adherence | 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. | ClinicalTrials.gov |
| Secondary | Cell salvage volumes | During surgery | Anticoagulant solution prepared and aspirated, and blood collected, processed and reinfused per episode (mL). | ClinicalTrials.gov |
| Secondary | Cell salvage consumables | During surgery | Use of collection set only, or collection and processing sets, per procedure. | ClinicalTrials.gov |
| Secondary | Reasons for cell salvage non-use in Group C | During surgery | Categorised as professional practice variation without a documented clinical reason, other documented reason, or not recorded. | ClinicalTrials.gov |
| Secondary | Re-exploration for bleeding or cardiac tamponade | From the day of surgery through hospital discharge, an average of 6 days | Unplanned return to the operating theatre for bleeding or cardiac tamponade. | ClinicalTrials.gov |
| Secondary | Other unplanned surgical reinterventions | From the day of surgery through hospital discharge, an average of 6 days | Unplanned surgical reinterventions other than re-exploration for bleeding. | ClinicalTrials.gov |
| Secondary | Acute kidney injury | 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. | ClinicalTrials.gov |
| Secondary | New-onset stroke or transient ischaemic attack | Up to hospital discharge or 30 days after surgery, whichever is later | New-onset stroke or transient ischaemic attack. | ClinicalTrials.gov |
| Secondary | Perioperative myocardial infarction | 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. | ClinicalTrials.gov |
| Secondary | New-onset postoperative atrial fibrillation | From the day of surgery through hospital discharge, an average of 6 days | New-onset atrial fibrillation after surgery. | ClinicalTrials.gov |
| Secondary | Surgical site infection or mediastinitis | From the day of surgery through hospital discharge, an average of 6 days | Surgical site infection or mediastinitis. | ClinicalTrials.gov |
| Secondary | Intensive care unit length of stay | 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. | ClinicalTrials.gov |
| Secondary | Hospital length of stay | From the day of surgery through hospital discharge, an average of 6 days | Days from the day of surgery to hospital discharge. | ClinicalTrials.gov |
| Secondary | In-hospital mortality | From the day of surgery through hospital discharge, an average of 6 days | Death from any cause during the index hospital stay. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)