About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Hemoadsorption