Haemoadsorption During Heart Transplantation

Heart Transplantation Clinical Trial

— CytoSorbHTX  

Official title:

Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270902
• Other study ID #: 1933/2021
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: Martin H. Bernardi, MD, PhD
• Phone: 0043140400
• Email: martin.bernardi[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing heart transplantation

Exclusion Criteria:

• Declined informed consent
• Age < 18 years#
• Receiving antileukocyte drugs
• Receiving TNF-a Blockers, immunosuppressive drugs (e.g. tocilizumab)
• DCD
• Ex-vivo perfusion

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Device:
• CytoSorb Adsorber
Polymer based adsorber system for the elimination of cytokines

Locations

Country	Name	City	State
Austria	Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in maximal cytokine peak levels (IL-1ß, IL-6, IL-33, TNF-a, IL-10)	Difference in maximal cytokine peak levels in various cytokine levels compared to baseline measured by ELISA	5 days
Secondary	Difference of immunosuppression (TTV)	Individual immunosuppression measured by Torque-teno-virus load	30days
Secondary	Difference of immunosuppression (sST2)	Individual immunosuppression measured by sST2 levels	30days
Secondary	primary graft dysfunction score	Differences in primary graft dysfunction score between both groups	7 days
Secondary	30-day mortality	Differences in 30-day mortality between both groups	30 days
Secondary	Mechanical Ventilation	Differences in length of mechanical ventilation	up to 4 weeks
Secondary	Delirium	Differences in Confusion assessment method for the ICU between both groups	5 days