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.
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
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)
Parallel
Hemoadsorption
DeviceThe 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.
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.)
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
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24 hours
Difference in the PELOD-2 score between before surgery and 24 hours after admission to intensive care. The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction)
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) worst value
Efficacy measured by the PELOD-2 worst value between admission to intensive care and 24 hours after admission to intensive care. The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction)
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 48 hours
PELOD-2 difference between groups in the PELOD-2 score measured between 24 hours and 48 hours after ICU admission. The higher the PELOD-2 the highest the probability of death.The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction).
Change in cytokine levels compared to baseline
Relative and absolute change in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (post-anestesia induction).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
