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Heart surgery bleeding study: does paying for fibrinogen change transfusion habits?

NCT ID NCT07457879

Knowledge-focused Sponsor: Erasme University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether making fibrinogen concentrate (a protein that helps blood clot) free for hospitals in Belgium changed how doctors manage bleeding during complex heart surgery. Researchers will compare transfusion rates and patient outcomes before and after the reimbursement policy started in April 2020. About 450 adults having complex heart surgery at one hospital will be included, using data from 2016 to 2024.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could show that making fibrinogen concentrate available changes how doctors manage bleeding during heart surgery, potentially reducing blood transfusions.
What could go wrong
This is an observational study, not a controlled trial, so it can only show associations, not cause and effect. Results may be influenced by other changes in practice over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged ≥ 18 years * Complex cardiac surgery under cardiopulmonary bypass (CPB), defined as: 1. Coronary artery bypass grafting combined with valve replacement 2. Replacement of two or more valves 3. Cardiac reoperation 4. Surgery for infective endocarditis 5. 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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac surgery

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • H.U.B - Hôpital Erasme

    Brussels, 1070, Belgium

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