Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial

Not Applicable

Recruiting

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

• Registration Number: NCT06512623
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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 cardiac surgery.

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 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.

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-22
• Study Start: 2024-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 (pregnancy test done as standard of care)
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemoadsorption	Hemoadsoprtion	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.

Primary Outcome Measures

Name	Time	Method
SOFA score at 24 hours	Within 24 hours of ICU admission	Difference between groups in the SOFA score measured within 24 hours after ICU admission

Secondary Outcome Measures

Name	Time	Method
Days alive without vasopressors	At day 28 from ICU admission	Number of days alive and without vasopressors
ICU, hospital, and 28 days (from ICU admission) mortality	At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission	All-cause mortality
ICU and hospital length of stay	At time of hospital discharge, an average 20 days after ICU admission	Lengths of stays, in days
Days alive without respiratory support	At day 28 from ICU admission	Number of days alive and without mechanical ventilation
Days alive without renal replacement therapy	At day 28 from ICU admission	Number of days alive and without renal replacement therapy
SOFA score at 48 hours	Measured between 24 hours and 48 hours after ICU admission	Sequential Organ Failure Assessment (SOFA) difference between groups in the SOFA score measured between 24hours and 48 hours after ICU admission. The higher the SOFA the highest the probability of death
Post-operative complications	At time of ICU discharge, up to 7 days after ICU admission	Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, delirium, liver injury or need for coronary angiography
Cytokines levels	at the end of CPB, at the admission in ICU and 24 hours after ICU admission	Relative and absolute reduction in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (immediately before CPB initiation).

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland