Health TrialsbyHealthPanel

Impact of the Reimbursement of Fibrinogen in Cardiac Surgery

ConditionCardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasme University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥ 18 years

Coronary artery bypass grafting combined with valve replacement

Replacement of two or more valves

Cardiac reoperation

Disqualifiers

Surgery without cardiopulmonary bypass (CPB)

Patients aged < 18 years

Pregnancy

Patients requiring postoperative extracorporeal membrane oxygenation (ECMO)

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

450 Participants
are grouped into 2 trial groups
Group A: Pre-reimbursement (Jan 1st, 2016 - march 31st, 2020)
Group B: Post-reimbursement (April 1st, 2020- Dec 31st, 2024)

Trial outcomes

Primary outcomes

1

Red blood cell transfusion

Total number of red blood cell units transfused per patient during the perioperative period.

Time frame
48 hours

Secondary outcomes

1

Use of fibrinogen concentrate

Proportion of patients receiving fibrinogen concentrate and total dose administered.

Time frame
48 hours
2

Plasma transfusion

Number of plasma units transfused per patient.

Time frame
48 hours
3

Platelet transfusion

Number of platelet units transfused per patient.

Time frame
48 hours
4

Reoperation for bleeding

Incidence of surgical re-exploration for postoperative bleeding.

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasme University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: