Cardiac Surgery
Conditions
Keywords
Cardiac surgery, Fibrinogen, Blood transfusion, Hemostasis, Transfusion practice, Perioperative bleeding
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Erasme University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 18 years * Complex cardiac surgery under cardiopulmonary bypass (CPB), defined as: 1. Coronary artery bypass grafting combined with valve replacement 2. Replacement of two or more valves 3. Cardiac reoperation 4. Surgery for infective endocarditis 5. Ascending aorta surgery * 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
* Surgery without cardiopulmonary bypass (CPB) * Patients aged \< 18 years * Pregnancy * Patients requiring postoperative extracorporeal membrane oxygenation (ECMO)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Red blood cell transfusion | 48 hours | Total number of red blood cell units transfused per patient during the perioperative period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | 28 days | Death occurring during the same hospital admission. |
| ICU length of stay | 28 days | Duration of stay in the intensive care unit, expressed in days. |
| Plasma transfusion | 48 hours | Number of plasma units transfused per patient. |
| Platelet transfusion | 48 hours | Number of platelet units transfused per patient. |
| Reoperation for bleeding | 28 days | Incidence of surgical re-exploration for postoperative bleeding. |
| Use of fibrinogen concentrate | 48 hours | Proportion of patients receiving fibrinogen concentrate and total dose administered. |
Countries
Belgium
Contacts
CONTACTCaroline Van Aelbrouck, MD
CONTACTLaurent Perrin, MD
PRINCIPAL_INVESTIGATORCaroline Van Aelbrouck, MD
H.U.B - Hôpital Erasme
Outcome results
None listed