NCT07457879

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2026

Completed
Last Updated

March 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Cardiac Surgery

Keywords

Cardiac surgeryFibrinogenBlood transfusionHemostasisTransfusion practicePerioperative bleeding

Outcome Measures

Primary Outcomes (1)

  • Red blood cell transfusion

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

    48 hours

Secondary Outcomes (6)

  • Use of fibrinogen concentrate

    48 hours

  • Plasma transfusion

    48 hours

  • Platelet transfusion

    48 hours

  • Reoperation for bleeding

    28 days

  • ICU length of stay

    28 days

  • +1 more secondary outcomes

Study Arms (2)

Pre-reimbursement (Jan 1st, 2016 - march 31st, 2020)

Patients undergoing complex cardiac surgery before fibrinogen reimbursement

Post-reimbursement (April 1st, 2020- Dec 31st, 2024)

Patients undergoing complex cardiac surgery after fibrinogen reimbursement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H.U.B - Hôpital Erasme

Brussels, 1070, Belgium

Location

Study Officials

  • Caroline Van Aelbrouck, MD

    H.U.B - Hôpital Erasme

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Van Aelbrouck, MD

CONTACT

+3225553324c.vanaelbrouck@hubruxelles.be

Laurent Perrin, MD

CONTACT

+3225553324laurent.perrin@hubruxelles.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

March 20, 2026

Primary Completion

May 31, 2026

Study Completion

June 10, 2026

Last Updated

March 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)