Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 10
SponsorCentre Hospitalier Universitaire Vaudois

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

Treatment groups

20 Participants
are divided into 2 treatment groups