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Haemoadsorption During Heart Transplantation

ConditionHeart Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients undergoing heart transplantation

Disqualifiers

Declined informed consent

Age < 18 years#

Receiving antileukocyte drugs

Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)

Trial design

Design model

Parallel

Treatments tested in this trial

  • CytoSorb Adsorber

    Device

    Polymer based adsorber system for the elimination of cytokines

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Adsorber GroupActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Time frame
5 days

Secondary outcomes

1

Difference of immunosuppression (TTV)

Individual immunosuppression measured by Torque-teno-virus load

Time frame
30days
2

Difference of immunosuppression (sST2)

Individual immunosuppression measured by sST2 levels

Time frame
30days
3

primary graft dysfunction score

Differences in primary graft dysfunction score between both groups

Time frame
7 days
4

30-day mortality

Differences in 30-day mortality between both groups

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov
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