Status:
RECRUITING
Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Post-cardiac Surgery
Inflammation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ca...
Detailed Description
Cardiopulmonary bypass (CPB) is an extracorporeal circuit used to divert blood from the heart and lungs and take over their functions during cardiac surgery. Cardiac surgery with CPB can induce a majo...
Eligibility Criteria
Inclusion
- 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
- 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
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Participation in another conflicting research study
Key Trial Info
Start Date :
October 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06512623
Start Date
October 27 2024
End Date
March 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011