H.U.B - Hôpital Erasme
Brussels, 1070, Belgium
Location contact
Caroline Van Aelbrouck, MD
CONTACT
Caroline Van Aelbrouck, MD
PRINCIPAL_INVESTIGATOR
Laurent Perrin, MD
CONTACT
NCT Number: NCT07457879
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Brussels, 1070, Belgium
Caroline Van Aelbrouck, MD
CONTACT
Caroline Van Aelbrouck, MD
PRINCIPAL_INVESTIGATOR
Laurent Perrin, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 48 hours
Total number of red blood cell units transfused per patient during the perioperative period.
Time frame: 48 hours
Proportion of patients receiving fibrinogen concentrate and total dose administered.
Time frame: 48 hours
Number of plasma units transfused per patient.
Time frame: 48 hours
Number of platelet units transfused per patient.
Time frame: 28 days
Incidence of surgical re-exploration for postoperative bleeding.
Time frame: 28 days
Duration of stay in the intensive care unit, expressed in days.
Time frame: 28 days
Death occurring during the same hospital admission.
Contact information is provided by the study sponsor or research team.
Caroline Van Aelbrouck, MD
CONTACT
Laurent Perrin, MD
CONTACT
Erasme University Hospital
Other
Impact of the Reimbursement of Fibrinogen on Transfusion, Mortality and Morbidity in Cardiac Surgery
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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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