AzTrials
AzTrials

Heart TransplantationCytoSorbHTXNCT05270902

Haemoadsorption During Heart Transplantation

A study testing CytoSorb Adsorber in people with Heart Transplantation, run by Medical University of Vienna at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Transplantation
What is being tested?
CytoSorb Adsorber
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteAustria
Study dates
1 Sep 2022to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients undergoing heart transplantation

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martin H. Bernardi, MD, PhD contact

0043140400 ext. 41090

martin.bernardi@meduniwien.ac.at

Austria1 site, 1 recruiting

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

    Vienna, State of Vienna, 1090

    Martin H Bernardi, MD, 004314040041090, martin.bernardi@meduniwien.ac.at

    Martin H Bernardi, MD

    Recruiting

Other trials in Austria

About this study

Official title: Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation

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

Being tested
CytoSorb Adsorber
Keywords
Heart Transplantation, Cytosorb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CytoSorb AdsorberDevice

    Polymer based adsorber system for the elimination of cytokines

Study groups in NCT05270902
Study groupRoleWhat they receive
Adsorber GroupActive comparatorSurgery 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.
Receives: Device: CytoSorb Adsorber
ControlNo interventionThe control group (no-adsorber group) will be treated similarly, but no filter circuit will be installed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5 days

Secondary outcomes (6)

  1. Difference of immunosuppression (TTV)

    Individual immunosuppression measured by Torque-teno-virus load

    Measured: 30days

  2. Difference of immunosuppression (sST2)

    Individual immunosuppression measured by sST2 levels

    Measured: 30days

  3. primary graft dysfunction score

    Differences in primary graft dysfunction score between both groups

    Measured: 7 days

  4. 30-day mortality

    Differences in 30-day mortality between both groups

    Measured: 30 days

  5. Mechanical Ventilation

    Differences in length of mechanical ventilation

    Measured: up to 4 weeks

  6. Delirium

    Differences in Confusion assessment method for the ICU between both groups

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2022
  2. Study start1 Sep 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, single-center, single-blinded, randomized, controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05270902
Sponsor's protocol ID
1933/2021
Acronym
CytoSorbHTX
Status last verified
May 2025
First submitted
2 Feb 2022
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: after completion of study, the results will be published in a peer reviewed journal

Questions about this trial

What is this clinical trial studying?

A study testing CytoSorb Adsorber in people with Heart Transplantation, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin H. Bernardi, MD, PhD (0043140400 ext. 41090, martin.bernardi@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10) (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05270902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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