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Tailored clotting treatment may cut bleeding after heart surgery

NCT ID NCT07425600

Knowledge-focused Sponsor: Centre Hospitalier Universitaire de Saint Etienne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to find the best dose of a clotting drug (fibrinogen) for patients after heart surgery using a heart-lung machine. Bleeding is a common complication, and current dosing is not personalized. Researchers will take blood samples from 150 adults to understand how fibrinogen levels change and how to give the minimum effective dose, potentially reducing bleeding and costs.

What this could mean

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

Active substance
fibrinogen concentrate
What this could lead to
If successful, this could lead to a personalized dosing strategy for fibrinogen after heart surgery, reducing bleeding and costs.
What could go wrong
This is an early observational study (not yet recruiting) with only 150 participants. It aims to understand variability, not to prove a new treatment works.

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 150 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

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

Patient admitted for cardiac surgery and receiving fibrinogen administration after weaning from cardiopulmonary bypass

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: * Adult * Patient undergoing cardiac surgery under cardiopulmonary bypass * Indication for fibrinogen administration after cardiopulmonary bypass weaning * Patient affiliated with or entitled to social security coverage * Patient who has received informed consent about the study Exclusion Criteria: * Administration of fibrinogen in the context of massive transfusion * Contraindication to the administration of the fibrinogen concentrate under study * Constitutional afibrinogenemia, constitutional dysfibrinogenemia, or any other constitutional diseases related to hemostasis * Pregnant women, women in labor, breastfeeding women * Adults subject to legal protection measures (guardianship or curatorship) * Patients with preoperative anemia \< 6 g/dL * Patients with a life expectancy \< 24 hours * Patients who do not speak French * Refusal to participate

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Conditions

The condition(s) this trial relates to.

congenital fibrinogen deficiency familial hypofibrinogenemia

As listed by the trial registrant

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

Fibrinogen deficiency in complex cardiac surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • CHU de Lille

    Lille, 59000, France

  • CHU de Saint-Etienne

    Saint-Etienne, 42000, France

More trials for these conditions

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