Post-cardiac SurgeryJACCSNCT06512623
Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial
A study testing Hemoadsoprtion in people with Post-cardiac Surgery and Inflammation, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-cardiac Surgery, Inflammation, Organ Dysfunction Syndrome
- What is being tested?
- Hemoadsoprtion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Oct 2024to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-cardiac Surgery, Inflammation, Organ Dysfunction Syndrome, Cardiac Disease, Cardio-Pulmonary Bypass
- Being tested
- Hemoadsoprtion
- Keywords
- Post-pump syndrom, Cytokine Hemoadsorption, Post-operative organ failure
- Medical subject headings
- Inflammation, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoadsoprtionDevice
The hemoadsorption treatment will be performed during the entire duration of the CPB. Blood flow within the cartridge is standardized at 250 ml/min.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care) |
| Hemoadsorption | Experimental | 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. Receives: Device: Hemoadsoprtion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score at 24 hours
Difference between groups in the SOFA score measured within 24 hours after ICU admission
Measured: Within 24 hours of ICU admission
Secondary outcomes (8)
ICU and hospital length of stay
Lengths of stays, in days
Measured: At time of hospital discharge, an average 20 days after ICU admission
ICU, hospital, and 28 days (from ICU admission) mortality
All-cause mortality
Measured: 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
Measured: At day 28 from ICU admission
Days alive without renal replacement therapy
Number of days alive and without renal replacement therapy
Measured: At day 28 from ICU admission
Days alive without vasopressors
Number of days alive and without vasopressors
Measured: 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: 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
Measured: 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).
Measured: at the end of CPB, at the admission in ICU and 24 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start27 Oct 2024
- Primary completion18 Dec 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Schneider, Centre Hospitalier Universitaire Vaudois
- Investigators
- Antoine Schneider, Principal investigator, CHUV Centre Hospitalier Universitaire Vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512623
- Sponsor's protocol ID
- CER-VD-2024-D0057
- Acronym
- JACCS
- Status last verified
- Jan 2026
- First submitted
- 1 Jul 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Adsorption During Complex Cardiac Surgery: the JACCS Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06512623
- Acronym / sponsor ID
- JACCS / CER-VD-2024-D0057
- Conditions
- Post-cardiac Surgery, Inflammation, Organ Dysfunction Syndrome, Cardiac Disease, Cardio-Pulmonary Bypass
- Keywords
- Post-pump syndrom, Cytokine Hemoadsorption, Post-operative organ failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 27 Oct 2024 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care) |
| Hemoadsorption | Experimental | Device: HemoadsoprtionCardiopulmonary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoadsoprtionThe hemoadsorption treatment will be performed during the entire duration of the CPB. Blood flow within the cartridge is standardized at 250 ml/min. | Device | Hemoadsorption |
Primary outcome
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
8 secondary outcomes
ICU and hospital length of stay
Time frame: At time of hospital discharge, an average 20 days after ICU admission
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
Days alive without respiratory support
Time frame: At day 28 from ICU admission
Days alive without renal replacement therapy
Time frame: At day 28 from ICU admission
Days alive without vasopressors
Time frame: At day 28 from ICU admission
SOFA score at 48 hours
Time frame: Measured between 24 hours and 48 hours after ICU admission
Post-operative complications
Time frame: At time of ICU discharge, up to 7 days after ICU admission
Cytokines levels
Time frame: at the end of CPB, at the admission in ICU and 24 hours after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Schneider principal investigator
CHUV Centre Hospitalier Universitaire Vaudois (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoadsoprtion in people with Post-cardiac Surgery and Inflammation, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA score at 24 hours (time frame: Within 24 hours of ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.