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New bleeding treatment tested in Kids' heart surgery

NCT ID NCT04376762

Disease control Sponsor: University of Virginia 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two treatments for bleeding after heart surgery in children aged 2 years or younger. One group received a purified fibrinogen concentrate, the other received cryoprecipitate (a blood product). The goal was to see if the concentrate works as well as cryoprecipitate to reduce the need for blood transfusions. The trial included 31 children and will help plan a larger study.

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 (Fibryga) and cryoprecipitate
What this could lead to
If it works, this could offer a safer, more standardized option to control bleeding in young children after heart surgery.
What could go wrong
This is a small pilot study with only 31 children, so results may not apply to all patients. The trial is not designed to prove superiority, only to guide a larger study.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

31 people

The number who actually took part.

Started

Oct 2021

Finished

May 2023

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.

Ages

Up to 24 months

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: * pediatric (age 24 months or younger) patients undergoing elective cardiac surgery with CPB (n=30) in-whom fibrinogen supplementation after separation from CPB is indicated, based on the presence of clinically-significant bleeding and documentation of low fibrinogen level on viscoelastic point-of-care testing (MCF \< 10 mm on the FIBTEM assay of ROTEM). Exclusion Criteria: * gestational age \< 33 weeks at birth * gestational age \< 35 weeks on the day of surgery * emergency surgery * patient or parent history of coagulopathy/clotting abnormalities * patient history of thrombophilia * refusal to participate in the study, * known severe allergic reaction/anaphylaxis to fibrinogen concentrate, * administration of fibrinogen concentrate or cryoprecipitate in the 24 hours prior to surgery * baseline fibrinogen level higher than 300 mg/dL (to avoid the risk of increasing the fibrinogen level above the normal upper level of 400 mg/dL)

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Conditions

The condition(s) this trial relates to.

Hemorrhage hemorrhagic disease

As listed by the trial registrant

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

Bleeding Pediatric HD

Contacts and locations

Locations

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.