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NCT Number: NCT05270902

Haemoadsorption During 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

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Key information

Conditions

Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Martin H Bernardi, MD

CONTACT

[email protected]

004314040041090

Martin H Bernardi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb Adsorber

Device

Polymer based adsorber system for the elimination of cytokines

Primary outcomes

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

    Time frame: 5 days

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

Secondary outcomes

  1. Difference of immunosuppression (TTV)

    Time frame: 30days

    Individual immunosuppression measured by Torque-teno-virus load

  2. Difference of immunosuppression (sST2)

    Time frame: 30days

    Individual immunosuppression measured by sST2 levels

  3. primary graft dysfunction score

    Time frame: 7 days

    Differences in primary graft dysfunction score between both groups

  4. 30-day mortality

    Time frame: 30 days

    Differences in 30-day mortality between both groups

  5. Mechanical Ventilation

    Time frame: up to 4 weeks

    Differences in length of mechanical ventilation

  6. Delirium

    Time frame: 5 days

    Differences in Confusion assessment method for the ICU between both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Martin H. Bernardi, MD, PhD

CONTACT

[email protected]

0043140400 ext. 41090

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation

Acronym: CytoSorbHTX

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 8, 2022
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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