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This retrospective, single-center observational study aims to evaluate the impact of fibrinogen concentrate reimbursement introduced in Belgium in April 1st, 2020, on transfusion practices in complex cardiac surgery. Adult patients undergoing complex cardiac surgery with cardiopulmonary bypass between Jan 1st 2016 and Dec 31st 2024 at Erasme Hospital will be included. Transfusion strategies and clinical outcomes will be compared between the pre-reimbursement and post-reimbursement periods.
Complex cardiac surgery with cardiopulmonary bypass is associated with a high risk of perioperative bleeding and transfusion. Since April 1st, 2020, fibrinogen concentrate has been reimbursed in Belgium, facilitating its use as a first-line treatment in fibrinogen deficiency identified by viscoelastic testing.
This retrospective, observational, single-center cohort study will analyze adult patients who underwent complex cardiac surgery with cardiopulmonary bypass at Erasme Hospital between Jan 1st 2016 and Dec 31st, 2024. Two distinct periods will be compared: a pre-reimbursement period (Jan 1st, 2016 to March 31st, 2020) and a post-reimbursement period (April 1st, 2020 to Dec 31st, 2024).
Clinical, biological, and transfusion-related data will be collected retrospectively from electronic medical records and blood bank databases. The primary objective is to evaluate changes in transfusion practices, including the use of red blood cells, plasma, platelets, fibrinogen concentrate, and prothrombin complex concentrates. Secondary objectives include postoperative bleeding, length of stay in intensive care and hospital, reoperation for bleeding, postoperative complications, and in-hospital mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-reimbursement (Jan 1st, 2016 - march 31st, 2020) | Patients undergoing complex cardiac surgery before fibrinogen reimbursement | ||
| Post-reimbursement (April 1st, 2020- Dec 31st, 2024) | Patients undergoing complex cardiac surgery after fibrinogen reimbursement |
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| Measure | Description | Time Frame |
|---|---|---|
| Red blood cell transfusion | Total number of red blood cell units transfused per patient during the perioperative period. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Use of fibrinogen concentrate | Proportion of patients receiving fibrinogen concentrate and total dose administered. | 48 hours |
| Plasma transfusion | Number of plasma units transfused per patient. |
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Inclusion Criteria:
Patients aged ≥ 18 years
Complex cardiac surgery under cardiopulmonary bypass (CPB), defined as:
Scheduled or emergency procedures
Complete clinical and biological data available (transfusions, hospital stay, complications, tests)
Surgery performed between Jan 1st, 2016 and Dec 31st, 2024
Exclusion Criteria:
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Adult patients (≥18 years) undergoing complex cardiac surgery requiring cardiopulmonary bypass (CPB) at CHU Erasme between Jan 1, 2016 and Dec 31, 2024.
The cohort includes scheduled and emergency procedures such as combined coronary bypass and valve replacement, multi-valve replacement, reoperations, infective endocarditis surgery, and ascending aorta surgery.
Patients without CPB, pregnant women, those requiring postoperative ECMO, or experiencing immediate perioperative death were excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Van Aelbrouck, MD | Contact | +3225553324 | c.vanaelbrouck@hubruxelles.be | |
| Laurent Perrin, MD | Contact | +3225553324 | laurent.perrin@hubruxelles.be |
| Name | Affiliation | Role |
|---|---|---|
| Caroline Van Aelbrouck, MD | H.U.B - Hôpital Erasme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H.U.B - Hôpital Erasme | Brussels | 1070 | Belgium |
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| 48 hours |
| Platelet transfusion | Number of platelet units transfused per patient. | 48 hours |
| Reoperation for bleeding | Incidence of surgical re-exploration for postoperative bleeding. | 28 days |
| ICU length of stay | Duration of stay in the intensive care unit, expressed in days. | 28 days |
| In-hospital mortality | Death occurring during the same hospital admission. | 28 days |