Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries

Starting soon · Not applicable

Conditions studied: Cardiac Surgery Recovery, Inflammation, Complex Cardiovascular Surgery With Cardiopulmonary Bypass, Cytokine Storm, Pediatric Open Heart Surgery

In brief

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.

Key facts

Study ID

NCT07393087

Run by

Centre Hospitalier Universitaire Vaudois

People needed

20

Starts

2026-03-01

Expected to finish

2029-04-01

Last updated by the study team

2026-02-10

Who can join

Age: any, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland

Full record on ClinicalTrials.gov

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