Cardiac SurgeryNCT07457879
Impact of the Reimbursement of Fibrinogen in Cardiac Surgery
An observational study of Cardiac Surgery, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2026to 10 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- Surgery without cardiopulmonary bypass (CPB)
- Patients aged < 18 years
- Pregnancy
- Patients requiring postoperative extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
H.U.B - Hôpital Erasme
Brussels, 1070
Caroline Van Aelbrouck, MD, +3225553324, c.vanaelbrouck@hubruxelles.be
Laurent Perrin, MD, +3225553324, laurent.perrin@hubruxelles.be
About this study
Official title: Impact of the Reimbursement of Fibrinogen on Transfusion, Mortality and Morbidity 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.
Read the detailed description
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.
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Fibrinogen, Blood transfusion, Hemostasis, Transfusion practice, Perioperative bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell transfusion
Total number of red blood cell units transfused per patient during the perioperative period.
Measured: 48 hours
Secondary outcomes (6)
Use of fibrinogen concentrate
Proportion of patients receiving fibrinogen concentrate and total dose administered.
Measured: 48 hours
Plasma transfusion
Number of plasma units transfused per patient.
Measured: 48 hours
Platelet transfusion
Number of platelet units transfused per patient.
Measured: 48 hours
Reoperation for bleeding
Incidence of surgical re-exploration for postoperative bleeding.
Measured: 28 days
ICU length of stay
Duration of stay in the intensive care unit, expressed in days.
Measured: 28 days
In-hospital mortality
Death occurring during the same hospital admission.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Van Aelbrouck, MD, Principal investigator, H.U.B - Hôpital Erasme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457879
- Sponsor's protocol ID
- HUB2025097
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Reimbursement of Fibrinogen on Transfusion, Mortality and Morbidity in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07457879
- Acronym / sponsor ID
- HUB2025097
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Fibrinogen, Blood transfusion, Hemostasis, Transfusion practice, Perioperative bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Patients aged ≥ 18 years
- Complex cardiac surgery under cardiopulmonary bypass (CPB), defined as:
- 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
Key exclusion criteria (4 listed)
- Surgery without cardiopulmonary bypass (CPB)
- Patients aged < 18 years
- Pregnancy
- Patients requiring postoperative extracorporeal membrane oxygenation (ECMO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Red blood cell transfusion
Time frame: 48 hours
Total number of red blood cell units transfused per patient during the perioperative period.
6 secondary outcomes
Use of fibrinogen concentrate
Time frame: 48 hours
Plasma transfusion
Time frame: 48 hours
Platelet transfusion
Time frame: 48 hours
Reoperation for bleeding
Time frame: 28 days
ICU length of stay
Time frame: 28 days
In-hospital mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Van Aelbrouck, MD principal investigator
H.U.B - Hôpital Erasme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Van Aelbrouck, MD (+3225553324, c.vanaelbrouck@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell transfusion (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.