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New device aims to tame inflammation in Kids' heart surgery

NCT ID NCT07393087

Knowledge-focused Sponsor: Centre Hospitalier Universitaire Vaudois 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a special filter (Jafron HA-60) used during heart-lung bypass in 20 children having open-heart surgery. The filter is designed to remove inflammatory substances from the blood, which may help reduce complications. The main goal is to see if using the filter is safe and practical in a hospital setting.

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 20 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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

Up to 10 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 ≤ 10 years old at study inclusion * Children weighing at least 5 kg at study inclusion * Planned for open-heart cardiac surgery with CPB-time ≥ 120 min and aortic clamping. * Informed consent obtained from parent(s)/legal representative Exclusion Criteria: * Children having an indication to receive hemoadsorption during CPB for drugs removal or other medically justified reason * Previous enrolment into the current study * Off-pump procedure * Chronic immunosuppression (chronic corticosteroid therapy, chemotherapy, anti-leucocyte drugs, TNF blockers or else) * Known allergy to heparin or heparin induced thrombocytopenia. * Severe thrombopenia (platelets count before surgery \< 20G/L) * Parent(s)/legal representative not able to understand/read French and/or English * Participation in another conflicting research study

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Conditions

The condition(s) this trial relates to.

cytokine release syndrome Inflammation inflammatory disease

As listed by the trial registrant

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

Cardiac surgery recovery Complex cardiovascular surgery with cardiopulmonary bypass Cytokine storm Inflammation Pediatric open heart surgery

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

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011, Switzerland

More trials for these conditions

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