Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries

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.

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.

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