CompletedNot Applicable

Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial

Switzerland41 participantsStarted 2024-10-27

Plain-language summary

This prospective single-centre randomized controlled trial aims at evaluating the safety and efficacy of hemoadsorption with HA-380® during cardio-pulmonary bypass in 40 patients undergoing complex cardiac surgery.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adults (≥18 years old at study inclusion)
✓. Planned for one of the following cardiac surgical procedures: heart transplantation after L-VAD (left ventricular assist device) implantation, OR surgical repair of a type A aortic dissection, OR urgent (within a few days) or emergent (within 24 hours) procedure for acute infectious endocarditis, OR cardiac surgery likely to require \>180 min CPB time as estimated by the surgical team
✓. Signed informed consent

Exclusion criteria

✕. Indication to receive hemoadsorption during CPB for drugs removal
✕. Women who are pregnant or breastfeeding
✕. Previous enrolment into the current study
✕. Off-pump procedure
✕. Chronic immunosuppression
✕. Known allergy to heparin or heparin induced thrombocytopenia
✕. Severe thrombopenia (platelets count before surgery \< 20g/L)
✕. Patient who does not want to be informed of incidental findings

What they're measuring

SOFA score at 24 hours

Timeframe: Within 24 hours of ICU admission

Trial details

NCT IDNCT06512623

SponsorCentre Hospitalier Universitaire Vaudois

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-18

View on ClinicalTrials.gov More Post-cardiac Surgery trials