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NCT Number: NCT06512623

Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized 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.

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Key information

Conditions

Post-cardiac Surgery Cardiac Disease Cardio-pulmonary Bypass Cardiovascular Diseases Heart Diseases Inflammation Organ Dysfunction Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Participation in another study with investigational drug within the 30 days preceding and during the present study
  • Participation in another conflicting research study

Treatment and study plan

Hemoadsoprtion

Device

The hemoadsorption treatment will be performed during the entire duration of the CPB. Blood flow within the cartridge is standardized at 250 ml/min.

Primary outcomes

  1. SOFA score at 24 hours

    Time frame: Within 24 hours of ICU admission

    Difference between groups in the SOFA score measured within 24 hours after ICU admission

Secondary outcomes

  1. ICU and hospital length of stay

    Time frame: At time of hospital discharge, an average 20 days after ICU admission

    Lengths of stays, in days

  2. ICU, hospital, and 28 days (from ICU admission) mortality

    Time frame: At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission

    All-cause mortality

  3. Days alive without respiratory support

    Time frame: At day 28 from ICU admission

    Number of days alive and without mechanical ventilation

  4. Days alive without renal replacement therapy

    Time frame: At day 28 from ICU admission

    Number of days alive and without renal replacement therapy

  5. Days alive without vasopressors

    Time frame: At day 28 from ICU admission

    Number of days alive and without vasopressors

  6. SOFA score at 48 hours

    Time frame: 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

  7. Post-operative complications

    Time frame: 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

  8. Cytokines levels

    Time frame: 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).

Other outcomes

  1. Device-related complications

    Time frame: During cardiopulmonary bypass

    Technical failure to perform the treatment (thrombosis of cartridge, circuit leak, inability to perform the treatment for all CPB duration)

  2. Treatment tolerance

    Time frame: During cardiopulmonary bypass

    New allergic or anaphylactoid reaction (stage ≥ 2 according to H. L. Mueller [39]) or new fever (> 38.5°C)

  3. Safety of intervention

    Time frame: From beginning of cardiopulmonary bypass to 7 days after ICU admission,

    Bleeding and haematological complications Post-operative infections New acute organ rejection

  4. Feasibility of intervention

    Time frame: During cardiopulmonary bypass

    Screened to enrolled patients' ratio, success of intervention delivery in intervention group, duration of recruitment

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: JACCS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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