Haemoadsorption During Heart Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CytoSorb Adsorber.
- Who it may be relevant to
- Registry conditions: Heart Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation
Overview
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
Interventions
- Device CytoSorb Adsorber
Polymer based adsorber system for the elimination of cytokines
Primary outcome measures
- Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10) [Time frame: 5 days]
Secondary outcome measures (6)
- Difference of immunosuppression (TTV) [Time frame: 30days]
- Difference of immunosuppression (sST2) [Time frame: 30days]
- primary graft dysfunction score [Time frame: 7 days]
- 30-day mortality [Time frame: 30 days]
- Mechanical Ventilation [Time frame: up to 4 weeks]
- Delirium [Time frame: 5 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of — Vienna
Identifiers
NCT: NCT05270902 · 1933/2021