Impact of the Reimbursement of Fibrinogen in Cardiac Surgery

Starting soon

Conditions studied: Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT07457879

Run by

Erasme University Hospital

People needed

450

Starts

2026-03-20

Expected to finish

2026-06-10

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥ 18 years
• Complex cardiac surgery under cardiopulmonary bypass (CPB), defined as:
• Coronary artery bypass grafting combined with valve replacement
• Replacement of two or more valves
• Cardiac reoperation
• Surgery for infective endocarditis
• 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

You may not qualify if…

• Surgery without cardiopulmonary bypass (CPB)
• Patients aged < 18 years
• Pregnancy
• Patients requiring postoperative extracorporeal membrane oxygenation (ECMO)

Where it is running

• H.U.B - Hôpital Erasme — Brussels, Belgium

Full record on ClinicalTrials.gov

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