Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial

Last updated: February 11, 2025
Sponsor: Centre Hospitalier Universitaire Vaudois
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Cardiac Disease

Treatment

Hemoadsoprtion

Clinical Study ID

NCT06512623
CER-VD-2024-D0057
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults (≥18 years old at study inclusion)

  2. Planned for one of the following cardiac surgical procedures: heart transplantationafter L-VAD (left ventricular assist device) implantation, OR surgical repair of atype A aortic dissection, OR urgent (within a few days) or emergent (within 24hours) procedure for acute infectious endocarditis, OR cardiac surgery likely torequire >180 min CPB time as estimated by the surgical team

  3. Signed informed consent

Exclusion

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 dayspreceding and during the present study

  10. Participation in another conflicting research study

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Hemoadsoprtion
Phase:
Study Start date:
October 21, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Vaud 1011
    Switzerland

    Active - Recruiting

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