Clincosm LogoSign in Get a demo

CytoSorbHTX: Haemoadsorption During Heart Transplantation

Sponsor
Medical University of Vienna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05270902
Collaborator
(none)
40
Enrollment
2
Arms
14.9
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: CytoSorb Adsorber
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, single-center, single-blinded, randomized, controlled trialProspective, single-center, single-blinded, randomized, controlled trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10) [5 days]

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

Secondary Outcome Measures

  1. Difference of immunosuppression (TTV) [30days]

    Individual immunosuppression measured by Torque-teno-virus load

  2. Difference of immunosuppression (sST2) [30days]

    Individual immunosuppression measured by sST2 levels

  3. primary graft dysfunction score [7 days]

    Differences in primary graft dysfunction score between both groups

  4. 30-day mortality [30 days]

    Differences in 30-day mortality between both groups

  5. Mechanical Ventilation [up to 4 weeks]

    Differences in length of mechanical ventilation

  6. Delirium [5 days]

    Differences in Confusion assessment method for the ICU between both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Martin Bernardi, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT05270902
Other Study ID Numbers:
  • 1933/2021
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Martin Bernardi, Principal Investigator, Medical University of Vienna
Heart Transplantation
Cytosorb

Study Results

No Results Posted as of Mar 29, 2022