Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries (JACKPOT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Cytokine Storm; Pediatric Open Heart Surgery; Cardiac Surgery Recovery; Complex Cardiovascular Surgery With Cardiopulmonary Bypass
• Intervention / Treatment: Device: Hemoadsorption

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Cristiani; Phone Number: +41 79 556 84 60; Email: isabelle.cristiani@chuv.ch
• Study Contact Backup: Name: Antoine Schneider, MD-PhD; Email: antoine.schneider@chuv.ch

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Contact: Antoine Schneider, MD-PhD; Phone Number: +41 79 556 68 72; Email: antoine.schneider@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care)
Experimental: Hemoadsorption; Cardiopulmonary bypass (CPB) will be conducted as per institutional protocols and an HA-60® cartridge (Jafron Biomedical, Guangdong, China) will be inserted within the circuit for hemoadsorption.	Device: Hemoadsorption; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screened-to-enrolled patients' ratio and number of intervention delivery group	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.)	Start CPB, End CPB, 1 Day and aftrer 28 day
Device-related adverse events	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	From beginning of cardiopulmonary bypass to 7 days after ICU admission or ICU discharge wichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU, hospital, and 28 days (from ICU admission) mortality	All-cause mortality	At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission
Days alive without respiratory support	Number of days alive and without mechanical ventilation	At day 28 from ICU admission
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 48 hours	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).	Measured between 24 hours and 48 hours after ICU admission
ICU and hospital lenght of stay	Lengths of stays, in days	At time of hospital discharge, an average 20 days after ICU admission
Days alive without renal replacement therapy	Number of days alive and without renal replacement therapy	At day 28 from ICU admission]
Days alive without vasopressors	Number of days alive and without vasopressors	At day 28 from ICU admission]
Days alive without ECMO support	Number of days alive and without Extracorporeal membrane oxygenation (ECMO)	At day 28 from ICU admission
Post-operative complications	Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, liver injury	At time of ICU discharge, up to 7 days after ICU admission
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24 hours	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)	Measured between post-anestesia induction and 24 hours post ICU-admission
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) worst value	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)	Within 4 hours of ICU admission
Change in cytokine levels compared to baseline	Relative and absolute change in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (post-anestesia induction).	at the end of CPB, at the admission in ICU and 24 hours after ICU admission

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Antoine Schneider, MD-PhD, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility pilot study; Hemoadsorption; Pediatric open heart surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Shock; Pathological Conditions, Signs and Symptoms; Cytokine Release Syndrome; Inflammation
• Other Study ID Numbers: CER-VD-2025-D0097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No