Haemoadsorption During Heart Transplantation (CytoSorbHTX)

March 13, 2023 updated by: Dr. Martin Bernardi, Medical University of Vienna

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Martin H Bernardi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: CytoSorb Adsorber
Polymer based adsorber system for the elimination of cytokines
No Intervention: Control
The control group (no-adsorber group) will be treated similarly, but no filter circuit will be installed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of immunosuppression (TTV)
Time Frame: 30days
Individual immunosuppression measured by Torque-teno-virus load
30days
Difference of immunosuppression (sST2)
Time Frame: 30days
Individual immunosuppression measured by sST2 levels
30days
primary graft dysfunction score
Time Frame: 7 days
Differences in primary graft dysfunction score between both groups
7 days
30-day mortality
Time Frame: 30 days
Differences in 30-day mortality between both groups
30 days
Mechanical Ventilation
Time Frame: up to 4 weeks
Differences in length of mechanical ventilation
up to 4 weeks
Delirium
Time Frame: 5 days
Differences in Confusion assessment method for the ICU between both groups
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Martin H. Bernardi, MD, PhD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 26, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1933/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

after completion of study, the results will be published in a peer reviewed journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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