Haemoadsorption During Heart Transplantation (CytoSorbHTX)

Medical University of Vienna

Status: Enrolling

Conditions: Heart Transplantation

Treatments: Device: CytoSorb Adsorber

Study type: Interventional

Funder types: Other

Identifiers

NCT05270902

1933/2021

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Adsorber Group

Active Comparator group

Description:

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.

Treatment:

Device: CytoSorb Adsorber

Control

No Intervention group

Description:

The control group (no-adsorber group) will be treated similarly, but no filter circuit will be installed.