Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial

NCT ID: NCT06512623

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-27
• Study Completion Date: 2026-01-12

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Hemoadsoprtion

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Antoine Schneider

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoine Schneider

Role: PRINCIPAL_INVESTIGATOR

CHUV Centre Hospitalier Universitaire Vaudois (CHUV)

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

CER-VD-2024-D0057

Identifier Type: -

Identifier Source: org_study_id