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New device could speed up bleeding checks in Kids' heart surgery

NCT ID NCT07597278

Diagnosis Sponsor: HemoSonics LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test a new device called the Quantra System to see how well it measures blood clotting in children undergoing heart surgery or with bleeding after surgery. The device gives quick results from a small blood sample. Researchers will compare its readings to those from standard clotting tests. The goal is to see if this device can help doctors manage bleeding more effectively in young patients.

What this could mean

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

Active substance
Quantra System with QPlus Cartridge (diagnostic device)
What this could lead to
If successful, this device could help doctors quickly assess bleeding risk in children during heart surgery, leading to better and faster treatment decisions.
What could go wrong
This is an early-stage study focused on comparing the device to existing methods. It does not test whether using the device actually improves patient outcomes, so real-world benefits are uncertain.

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 160 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population includes pediatric patients \<18 years of age that are undergoing cardiovascular procedures.

Ages

Up to 18 years

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: * Subject is \<18 years of age. * Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit. * Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form. Exclusion Criteria: * Corrected gestational age \<37 weeks. * Subject is enrolled in a study that might confound the result of the proposed study. * Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical

As listed by the trial registrant

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

Blood loss, surgical

How to take part

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

  1. The places running it

    3 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

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • UCLA Mattel Children's Hospital

    Los Angeles, California, 90095, United States

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