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Blood protein test could predict Post-Surgery risks in kids with heart defects

NCT ID NCT06642662

Knowledge-focused Sponsor: Boston Children's Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 at Boston Children's Hospital will test whether measuring thousands of proteins in a few drops of blood can predict which children with congenital heart disease will have serious complications after heart surgery. Researchers will collect blood samples from 60 children before and after surgery and combine protein profiles with clinical data to build a risk-prediction model. The goal is to move from a one-size-fits-all approach to personalized care in the Cardiac ICU.

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 could lead to a blood test that helps doctors predict which children are at highest risk for complications after heart surgery, allowing earlier and more personalized treatment.
What could go wrong
This is a small, early feasibility study (60 participants) that is only looking for patterns in proteins, not testing any treatment. The findings may not lead to a usable prediction tool or improve outcomes.

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 60 people

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

Started

Apr 2025

Expected to finish

Apr 2027

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

Prospective patients undergoing S1P for HLHS, BiV repair, or ASO will be identified. Inclusion: elective BiV repair in patients aged \>1 and \<5 years or standard risk S1P/ASO. Exclusion: preoperative ventilation or vasoactive support. With primary treating team approval, the investigators will approach parents of eligible patients to discuss study participation with written informed consent obtained if they agree to enroll.

Ages

2 days to 5 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: * consent from parents * cardiac surgical criteria and age criteria; elective BiV repair in patients aged \>1 and \<5 years or standard risk S1P/ASO Exclusion Criteria: * preoperative ventilation or vasoactive support or ECMO

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Conditions

The condition(s) this trial relates to.

congenital heart disease hypoplastic left heart syndrome transposition of the great arteries

As listed by the trial registrant

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

Congenital heart disease

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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