Haemoadsorption During Heart Transplantation

NCT ID: NCT05270902

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Heart Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, single-center, single-blinded, randomized, controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Adsorber Group

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.

Group Type ACTIVE_COMPARATOR

CytoSorb Adsorber

Intervention Type DEVICE

Polymer based adsorber system for the elimination of cytokines

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CytoSorb Adsorber

Polymer based adsorber system for the elimination of cytokines

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing heart transplantation

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Dr. Martin Bernardi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin H. Bernardi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Martin H. Bernardi, MD, PhD

Role: CONTACT

0043140400 ext. 41090

Facility Contacts

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Martin H Bernardi, MD

Role: primary

004314040041090

Other Identifiers

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1933/2021

Identifier Type: -

Identifier Source: org_study_id

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