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Could clear priming reduce inflammation after infant heart surgery?

NCT ID NCT07393243

Symptom relief Sponsor: Seattle 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether using clear, non-blood fluids to fill the heart-lung machine during surgery can reduce inflammation in infants having a hole in the heart repaired. Sixty babies aged 1 to 18 months will be enrolled. Researchers will measure inflammation markers and recovery times to see if the clear priming method is better than using donated blood.

What this could mean

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

Active substance
non-blood priming fluid
What this could lead to
If it works, this could lead to a safer way to perform heart surgery in infants, reducing inflammation and speeding recovery.
What could go wrong
This is a small, early-stage study with only 60 participants, so results may not apply to all children. The non-blood prime may not reduce inflammation as hoped.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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.

Ages

1 month to 18 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: * Weight between 5-10kg * Age 1-18 months * Requiring cardiopulmonary bypass as part of clinically indicated surgery * Surgery performed by Dr. Bohuta or Dr. Greene Exclusion Criteria: * Hemoglobin/hematocrit too low for clear CPB prime (post-dilution Hct \<24%) * Pre-operative ECMO support * Active infection * Not clinically appropriate for clear prime (instability, arrhythmias, desaturation, etc.) * Genetic syndrome * Pork allergy or family requests pork avoidance

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Conditions

The condition(s) this trial relates to.

Inflammation ventricular septal defect

As listed by the trial registrant

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

Ventricular septal defect

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

    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

  • Seattle Children's Hospital

    Seattle, Washington, 98115, United States

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