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

Cytokine Adsorption During Complex Cardiac Surgery: the JACCS Controlled Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Cardiac Disease; Post-cardiac Surgery; Organ Dysfunction Syndrome; Cardio-Pulmonary Bypass
• Intervention / Treatment: Device: Hemoadsoprtion

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care)
Experimental: Hemoadsorption; 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.	Device: Hemoadsoprtion; The hemoadsorption treatment will be performed during the entire duration of the CPB. Blood flow within the cartridge is standardized at 250 ml/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA score at 24 hours	Difference between groups in the SOFA score measured within 24 hours after ICU admission	Within 24 hours of ICU admission

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related complications	Technical failure to perform the treatment (thrombosis of cartridge, circuit leak, inability to perform the treatment for all CPB duration)	During cardiopulmonary bypass
Treatment tolerance	New allergic or anaphylactoid reaction (stage ≥ 2 according to H. L. Mueller [39]) or new fever (> 38.5°C)	During cardiopulmonary bypass
Safety of intervention	Bleeding and haematological complications Post-operative infections New acute organ rejection	From beginning of cardiopulmonary bypass to 7 days after ICU admission,
Feasibility of intervention	Screened to enrolled patients' ratio, success of intervention delivery in intervention group, duration of recruitment	During cardiopulmonary bypass

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Antoine Schneider, CHUV Centre Hospitalier Universitaire Vaudois (CHUV)

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2024
• Primary Completion (Actual): December 18, 2025
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cytokine Hemoadsorption; Post-pump syndrom; Post-operative organ failure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Heart Diseases
• Other Study ID Numbers: CER-VD-2024-D0057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No