Haemoadsorption During Heart Transplantation

Study Overview
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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

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

Conditions
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Heart Transplantation

Intervention / Treatment
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* Device: CytoSorb Adsorber


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-center, single-blinded, randomized, controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) | 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) | Individual immunosuppression measured by Torque-teno-virus load | 30days | 
| Difference of immunosuppression (sST2) | Individual immunosuppression measured by sST2 levels | 30days | 
| primary graft dysfunction score | Differences in primary graft dysfunction score between both groups | 7 days | 
| 30-day mortality | Differences in 30-day mortality between both groups | 30 days | 
| Mechanical Ventilation | Differences in length of mechanical ventilation | up to 4 weeks | 
| Delirium | Differences in Confusion assessment method for the ICU between both groups | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Transplantation, Cytosorb