NCT06512623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 27, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

July 1, 2024

Last Update Submit

January 21, 2026

Conditions

Post-cardiac SurgeryInflammationCardiac DiseaseCardio-Pulmonary BypassOrgan Dysfunction Syndrome

Keywords

Post-pump syndromCytokine HemoadsorptionPost-operative organ failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • ICU and hospital length of stay

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

  • ICU, hospital, and 28 days (from ICU admission) 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

    At day 28 from ICU admission

  • Days alive without renal replacement therapy

    At day 28 from ICU admission

  • Days alive without vasopressors

    At day 28 from ICU admission

  • +3 more secondary outcomes

Other Outcomes (4)

  • Device-related complications

    During cardiopulmonary bypass

  • Treatment tolerance

    During cardiopulmonary bypass

  • Safety of intervention

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

  • +1 more other outcomes

Study Arms (2)

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.

Device: Hemoadsoprtion

Interventions

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.

Hemoadsorption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

InflammationHeart Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular Diseases

Study Officials

  • Antoine Schneider

    CHUV Centre Hospitalier Universitaire Vaudois (CHUV)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 22, 2024

Study Start

October 27, 2024

Primary Completion

December 18, 2025

Study Completion

January 12, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)