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NCT Number: NCT07457879

Impact of the Reimbursement of Fibrinogen in Cardiac Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Red blood cell transfusion

    Time frame: 48 hours

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

Secondary outcomes

  1. Use of fibrinogen concentrate

    Time frame: 48 hours

    Proportion of patients receiving fibrinogen concentrate and total dose administered.

  2. Plasma transfusion

    Time frame: 48 hours

    Number of plasma units transfused per patient.

  3. Platelet transfusion

    Time frame: 48 hours

    Number of platelet units transfused per patient.

  4. Reoperation for bleeding

    Time frame: 28 days

    Incidence of surgical re-exploration for postoperative bleeding.

  5. ICU length of stay

    Time frame: 28 days

    Duration of stay in the intensive care unit, expressed in days.

  6. In-hospital mortality

    Time frame: 28 days

    Death occurring during the same hospital admission.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Van Aelbrouck, MD

CONTACT

[email protected]

+3225553324

Laurent Perrin, MD

CONTACT

[email protected]

+3225553324

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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