RecruitingNot ApplicableNCT05526950

Cytokine Filtration in Lung Transplantation: A Swedish National Study (GLUSorb)

Cytokine Filtration in Lung Transplantation - a Randomised, Controlled, Multicentre Clinical Trial (GLUSorb)


Sponsor

Lund University Hospital

Enrollment

116 participants

Start Date

Sep 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality. PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival. The present study is a randomized controlled study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

  • • Eligibility to undergo double lung transplantation at either trial site

Exclusion Criteria6

  • Age \<18 years
  • Previous organ transplantation
  • Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as:
  • Cyclosporine, Tacrolimus, Everolimus, or Sirolimus, minimum 1 month of treatment prior to transplantation and active treatment at the time of transplantation.
  • Any form of antibody-based treatment that is known for having an immunomodulatory effect taken up to 1 week before transplantation.
  • Non-consent

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Interventions

DEVICEDevice: CytoSorb

Medical device used hemoperfusion and cytokine adsorption in conjunction with lung transplantation.


Locations(1)

Sandra Lindstedt

Lund, Skåne County, Sweden

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NCT05526950


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