Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial (JACCS)

Vaud University Hospital Center

Status: Completed

Conditions: Inflammation; Cardiac Disease; Organ Dysfunction Syndrome; Post-cardiac Surgery; Cardio-Pulmonary Bypass

Treatments: Device: Hemoadsoprtion

Study type: Interventional

Funder types: Other

Identifiers

NCT06512623

CER-VD-2024-D0057

Details and patient eligibility

About

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.

Full 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 major inflammatory response, largely mediated by cytokines. In the most severe cases, this inflammation can lead to vasoplegia, hypotension and potentially end-organ damage.

The investigators hypothesised that the removal of inflammatory mediators (e.g. cytokines) from the blood during CPB could reduce the development of postoperative complications in patients with significant inflammation during cardiac surgery.

Patients undergoing complex cardiac surgery will be enrolled preoperatively and randomised 1:1 to receive either the investigational hemoadsorption treatment plus standard care (intervention group) or standard care alone (control group). Patients allocated to the intervention group will have an HA-380® cartridge (Jafron Biomedical, Guangdong, China) inserted into the CPB during circuit set-up. Hemoadsorption treatment will be performed throughout the duration of the CPB procedure.

For each patient, 4 blood samples will be taken for cytokine measurements (at the start of CPB, at the end of CPB, at ICU admission and 24 hours later). Data on vital signs, organs support, demographics and medical history will be collected in the electronic medical record.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults (≥18 years old at study inclusion)
2. 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
3. Signed informed consent

Exclusion criteria

1. Indication to receive hemoadsorption during CPB for drugs removal
2. Women who are pregnant or breastfeeding
3. Previous enrolment into the current study
4. Off-pump procedure
5. Chronic immunosuppression
6. Known allergy to heparin or heparin induced thrombocytopenia
7. Severe thrombopenia (platelets count before surgery < 20g/L)
8. Patient who does not want to be informed of incidental findings
9. Participation in another study with investigational drug within the 30 days preceding and during the present study
10. Participation in another conflicting research study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Control

No Intervention group

Description:

Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care)

Hemoadsorption

Experimental group

Description:

Cardiopulmonary bypass (CPB) will be conducted as per institutional protocols and an HA-380® cartridge (Jafron Biomedical, Guangdong, China) will be inserted within the circuit for hemoadsorption.

Treatment:

Device: Hemoadsoprtion