Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries
NCT07393087 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-10
Summary
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.
Conditions
- Cardiac Surgery Recovery
- Inflammation
- Complex Cardiovascular Surgery With Cardiopulmonary Bypass
- Cytokine Storm
- Pediatric Open Heart Surgery
Interventions
- DEVICE
-
Hemoadsorption
The 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.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire Vaudois
lead OTHER
Principal Investigators
-
Antoine Schneider, MD-PhD · Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2029-03-31
- Completion
- 2029-04-30
Countries
- Switzerland
Study Locations
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