NCT07457879

Impact of the Reimbursement of Fibrinogen in Cardiac Surgery

Impact of the Reimbursement of Fibrinogen on Transfusion, Mortality and Morbidity in Cardiac Surgery

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery

Timeline

• Start date: 2026-03-20
• Primary completion: 2026-05-31
• Completion: 2026-06-10
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: Belgium