Cardiac Surgery RecoveryJACKPOTNCT07393087
Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries
A study testing Hemoadsorption in people with Cardiac Surgery Recovery and Inflammation, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Cardiac Surgery Recovery, Inflammation, Complex Cardiovascular Surgery With Cardiopulmonary Bypass
- What is being tested?
- Hemoadsorption
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2026to Apr 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antoine Schneider, MD-PhD contact
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Antoine Schneider, MD-PhD, +41 79 556 68 72, antoine.schneider@chuv.ch
About this study
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.
Read the 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.
- Conditions
- Cardiac Surgery Recovery, Inflammation, Complex Cardiovascular Surgery With Cardiopulmonary Bypass, Cytokine Storm, Pediatric Open Heart Surgery
- Being tested
- Hemoadsorption
- Keywords
- Feasibility pilot study, Pediatric open heart surgery, Hemoadsorption
- Medical subject headings
- Inflammation, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoadsorptionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemoadsorption | Experimental | 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. Receives: Device: Hemoadsorption |
| Control | No intervention | Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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
Measured: From beginning of cardiopulmonary bypass to 7 days after ICU admission or ICU discharge wichever occurs first.
Secondary outcomes (11)
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: 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)
Measured: Within 4 hours of 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: Measured between 24 hours and 48 hours after 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).
Measured: at the end of CPB, at the admission in ICU and 24 hours after ICU admission
ICU and hospital lenght of stay
Lengths of stays, in days
Measured: At time of hospital discharge, an average 20 days after ICU admission
ICU, hospital, and 28 days (from ICU admission) mortality
All-cause mortality
Measured: 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
Measured: At day 28 from ICU admission
Days alive without renal replacement therapy
Number of days alive and without renal replacement therapy
Measured: At day 28 from ICU admission]
Days alive without vasopressors
Number of days alive and without vasopressors
Measured: At day 28 from ICU admission]
Days alive without ECMO support
Number of days alive and without Extracorporeal membrane oxygenation (ECMO)
Measured: At day 28 from ICU admission
Post-operative complications
Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, liver injury
Measured: At time of ICU discharge, up to 7 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Schneider, Centre Hospitalier Universitaire Vaudois
- Investigators
- Antoine Schneider, MD-PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393087
- Sponsor's protocol ID
- CER-VD-2025-D0097
- Acronym
- JACKPOT
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No