Haemoadsorption During Heart Transplantation

NCT05270902 | Recruiting

• 1 other identifier: 1933/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated

Conditions

Heart Transplantation

Keywords

Heart Transplantation; Cytosorb

Outcome Measures

Primary Outcomes (1)

• Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10)

  Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA

  5 days

Secondary Outcomes (6)

• Difference of immunosuppression (TTV)

  30days

• Difference of immunosuppression (sST2)

  30days

• primary graft dysfunction score

  7 days

• 30-day mortality

  30 days

• Mechanical Ventilation

  up to 4 weeks

Study Arms (2)

Adsorber Group

ACTIVE COMPARATOR

Surgery with CPB will be performed according to institutional standards, depending on indications and surgical preferences. For the intervention group (adsorber-group), the CytoSorb adsorber will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 300-400 ml.min-1.

Device: CytoSorb Adsorber

Control

NO INTERVENTION

The control group (no-adsorber group) will be treated similarly, but no filter circuit will be installed.

Interventions

CytoSorb Adsorber DEVICE

Polymer based adsorber system for the elimination of cytokines

Adsorber Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing heart transplantation

You may not qualify if:

• Declined informed consent
• Age \< 18 years#
• Receiving antileukocyte drugs
• Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
• DCD
• Ex-vivo perfusion

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Study Officials

• Martin H. Bernardi, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin H. Bernardi, MD, PhD

CONTACT

0043140400; martin.bernardi@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, single-center, single-blinded, randomized, controlled trial

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 8, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)