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NCT Number: NCT07393087

Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries

This prospective single-center randomized controlled trial aims at evaluating the safety and feasibility of an hemoadsorption protocol using Jafron HA-60 during cardio-pulmonary bypass in 20 pediatric patients undergoing open-heart surgery.

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Key information

Conditions

Cardiac Surgery Recovery Complex Cardiovascular Surgery With Cardiopulmonary Bypass Cytokine Release Syndrome Cytokine Storm Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Open Heart Surgery Shock Systemic Inflammatory Response Syndrome

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location contact

Antoine Schneider, MD-PhD

CONTACT

[email protected]

+41 79 556 68 72

About this study

Cardiopulmonary bypass (CPB) is an extracorporeal system that temporarily takes over the functions of the heart and lungs by diverting blood during cardiac surgery. However, the use of CPB is know to trigger a significant systemic inflammatory response, largely mediated by cytokines. In severe cases, this response may result in vasoplegia, hypotension, and subsequent organ dysfunction. Several pharmacological interventions have been investigated to reduce the incidence and severity of this post-surgical inflammatory response, but results have been very mitagated. Among emerging strategies, the pre-procedural removal of circulating cytokines through hemoadsorption represents a promising approach. In particular the use of a HA-60® cartridge (Jafron Biomedical, Guangdong, China) integrated into the CPB circuit may help attenuate the inflammatory cascade.

This pilot study is designed to evaluate the feasibility and safety of implementing an hemoadsorption protocol during cardiopulmonary bypass in a pediatric population. Pediatric patients scheduled for complex cardiac procedures will be enrolled before surgery and randomly assigned in a 1:1 ratio to either receive hemoadsorption therapy with standard care (intervention group) or standard care alone (control group).

In the intervention group, an HA-60® hemoadsorption cartridge will be integrated into the CPB circuit during setup and used throughout the duration of the bypass. Four blood samples will be collected : Post-anestesia induction, CPB termination, ICU admission, and 24 hours post ICU admission-to measure cytokine levels. Clinical data, including vital signs, organ support, demographics, and medical history, will be recorded in the electronic medical records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemoadsorption

Device

The hemoadsorption treatment will be performed during the entire duration of the CPB. The blood flow within the hemoadsorber will be controlled and set to 7% of the theoretical minimal CPB flow which is calculated as 2.5 L/min/1.73m2 of body surface area.

Primary outcomes

  1. Screened-to-enrolled patients' ratio and number of intervention delivery group

    Time frame: Start CPB, End CPB, 1 Day and aftrer 28 day

    • Screened-to-enrolled patients' ratio ≥ 0.3*
    • ≥ 80% of intervention delivery in intervention group (number of patients who received hemoadsorption > 50% of CPB duration)
    • Duration of recruitment: no more than 36 months (approximately 0.56 patient per month)
    • <5% of study interruptions attribuable to insufficiant resources or logistical constraints *(Previous pilot studies in intervention contexts report screened-to-enrolled patient ratios of approximately 0.30-0.50; therefore a threshold of ≥ 0.30 has been chosen as a minimal acceptable benchmark for feasibility.)

  2. Device-related adverse events

    Time frame: From beginning of cardiopulmonary bypass to 7 days after ICU admission or ICU discharge wichever occurs first.

    Assessed with the occurrence of 4 categories of adverse events in each group:

    Device-related complications:

    • Technical failure to perform the treatment: thrombosis of the cartridge, circuit leak or inability to perform the treatment for all CPB duration.

    Tolerance:

    • New allergic or anaphylactoid reaction (stage ≥ 2 by H. L. Mueller [5])
    • New fever (> 39°C for more than an hour).

    Bleeding/haematological complications*:

    • Intracranial haemorrhages
    • Need for massive transfusion (>10mL/kg/h during more than 3 consecutive hours)
    • Incidence of new thrombocytopenia (mild <150 G/L, moderate, <100 G/L severe < 50 G/L) *(We will consider separately bleeding/haematological complications occurring during the procedure (from CPB initiation to ICU admission) and those occurring from ICU admission to day 7 or ICU discharge, whichever occurs first.)

    All other event judged relevant by the investigator (i.e. cardiac arrest). NB: "New" means not present at the time of CPB initiation

Secondary outcomes

  1. Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24 hours

    Time frame: Measured between post-anestesia induction and 24 hours post ICU-admission

    Difference in the PELOD-2 score between before surgery and 24 hours after admission to intensive care. The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction)

  2. Pediatric Logistic Organ Dysfunction-2 (PELOD-2) worst value

    Time frame: Within 4 hours of ICU admission

    Efficacy measured by the PELOD-2 worst value between admission to intensive care and 24 hours after admission to intensive care. The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction)

  3. Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 48 hours

    Time frame: Measured between 24 hours and 48 hours after ICU admission

    PELOD-2 difference between groups in the PELOD-2 score measured between 24 hours and 48 hours after ICU admission. The higher the PELOD-2 the highest the probability of death.The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction).

  4. Change in cytokine levels compared to baseline

    Time frame: at the end of CPB, at the admission in ICU and 24 hours after ICU admission

    Relative and absolute change in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (post-anestesia induction).

  5. ICU and hospital lenght of stay

    Time frame: At time of hospital discharge, an average 20 days after ICU admission

    Lengths of stays, in days

  6. ICU, hospital, and 28 days (from ICU admission) mortality

    Time frame: At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission

    All-cause mortality

  7. Days alive without respiratory support

    Time frame: At day 28 from ICU admission

    Number of days alive and without mechanical ventilation

  8. Days alive without renal replacement therapy

    Time frame: At day 28 from ICU admission]

    Number of days alive and without renal replacement therapy

  9. Days alive without vasopressors

    Time frame: At day 28 from ICU admission]

    Number of days alive and without vasopressors

  10. Days alive without ECMO support

    Time frame: At day 28 from ICU admission

    Number of days alive and without Extracorporeal membrane oxygenation (ECMO)

  11. Post-operative complications

    Time frame: At time of ICU discharge, up to 7 days after ICU admission

    Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, liver injury

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Schneider, MD-PhD

CONTACT

[email protected]

Isabelle Cristiani

CONTACT

[email protected]

+41 79 556 84 60

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Acronym: JACKPOT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 6, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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