Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries

NCT07393087 | Not Yet Recruiting

• 1 other identifier: CER-VD-2025-D0097
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery Recovery; Inflammation; Complex Cardiovascular Surgery With Cardiopulmonary Bypass; Cytokine Storm; Pediatric Open Heart Surgery

Keywords

Feasibility pilot study; Pediatric open heart surgery; Hemoadsorption

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

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

  Measured between post-anestesia induction and 24 hours post ICU-admission

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

  Within 4 hours of ICU admission

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

  Measured between 24 hours and 48 hours after ICU admission

• Change in cytokine levels compared to baseline

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

• ICU and hospital lenght of stay

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

Study Arms (2)

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.

Device: Hemoadsorption

Control

NO INTERVENTION

Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care)

Interventions

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.

Hemoadsorption

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Planned for open-heart cardiac surgery with CPB-time ≥ 120 min and aortic clamping.
• Informed consent obtained from parent(s)/legal representative

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Inflammation; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Shock

Study Officials

• Antoine Schneider, MD-PhD

  Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Cristiani

CONTACT

+41 79 556 84 60; isabelle.cristiani@chuv.ch

Antoine Schneider, MD-PhD

CONTACT

antoine.schneider@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)