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Can a blood filter tame the inflammatory storm after pediatric heart surgery?

NCT ID NCT07771491

Disease control Sponsor: Norfaniza Zabidi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether adding a blood-filtering device, called hemoadsorption, to the heart-lung machine can reduce harmful inflammation in children undergoing complex open-heart surgery. The device is designed to remove inflammatory proteins, known as cytokines, from the blood during the procedure. Researchers will compare children who receive this therapy plus standard care against those receiving standard care alone, measuring inflammation levels and recovery outcomes.

What this could mean

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

Active substance
Hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge, which filters inflammatory proteins (cytokines) from the blood during cardiopulmonary bypass.
What this could lead to
If effective, this could reduce post-surgical complications, shorten ICU stays, and improve recovery for children undergoing major heart surgery.
What could go wrong
This is a single-center trial, and the outcome is still uncertain. The device may not significantly reduce inflammation or improve outcomes, and there are potential risks like bleeding or device-related complications.

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 120 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 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.

Ages

0 to 17 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: * Children (\<18 years old at study inclusion) * Undergoing a cardiac surgery with CPB of expected duration \> 180min * Prophylactic application of HA during CPB for suspected SIRS. Exclusion Criteria: * Non-ability to gather informed consent from parents or legal representative. Enrolled in conflicting research study * Off-pump procedure * Non-steroidal anti-inflammatory treatment in the previous 7 days Pregnancy

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Cardiopulmonary bypass Congenital heart disease Cyanotic heart disease Endocarditis acute and subacute Open heart surgery

How to take part

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

  1. 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 ↗

  2. 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.

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