Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries

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.

• Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24 hours [Time frame: Measured between post-anestesia induction and 24 hours post ICU-admission]
• Pediatric Logistic Organ Dysfunction-2 (PELOD-2) worst value [Time frame: Within 4 hours of ICU admission]
• Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 48 hours [Time frame: Measured between 24 hours and 48 hours after ICU admission]
• 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]
• ICU and hospital lenght of stay [Time frame: At time of hospital discharge, an average 20 days after ICU admission]
• 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]
• Days alive without respiratory support [Time frame: At day 28 from ICU admission]
• Days alive without renal replacement therapy [Time frame: At day 28 from ICU admission]]
• Days alive without vasopressors [Time frame: At day 28 from ICU admission]]
• Days alive without ECMO support [Time frame: At day 28 from ICU admission]
• Post-operative complications [Time frame: At time of ICU discharge, up to 7 days after ICU admission]