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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

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

Locations
Other Locations
Sweden
Sandra Lindstedt
RECRUITING
Lund
Contact Information
Primary
Sandra Lindstedt, MD,PhD
sandra.lindstedt_ingemansson@med.lu.se
+46737220580
Backup
Jesper Magnusson, MD, PhD
jesper.magnusson@vgregion.se
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 116
Treatments
Active_comparator: Treated
Treatment using the medical cytokine adsorption device in conjunction with lung transplantation
No_intervention: Non-treated
No additional treatment in conjunction with lung transplantation
Related Therapeutic Areas
Sponsors
Leads: Lund University Hospital

This content was sourced from clinicaltrials.gov