NCT05526950 Cytokine Filtration in Lung Transplantation: A Swedish National Study (GLUSorb)
| NCT ID | NCT05526950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University Hospital |
| Condition | Lung Transplant Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2023-09-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2023-09-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: • Eligibility to undergo double lung transplantation at either trial site Exclusion Criteria: 1. Age \<18 years 2. Previous organ transplantation 3. Presence of any conditions at the time of surgery that require immunosuppressive therapy. Immunosuppressive therapy is defined as: 1. Cyclosporine, Tacrolimus, Everolimus, or Sirolimus, minimum 1 month of treatment prior to transplantation and active treatment at the time of transplantation. 2. Any form of antibody-based treatment that is known for having an immunomodulatory effect taken up to 1 week before transplantation. 4. Non-consent
Contact & Investigator
Sandra Lindstedt, MD, PhD
PRINCIPAL INVESTIGATOR
Skånes universitetssjukhus Lund
Frequently Asked Questions
Who can join the NCT05526950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lung Transplant Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05526950 currently recruiting?
Yes, NCT05526950 is actively recruiting participants. Contact the research team at sandra.lindstedt_ingemansson@med.lu.se for enrollment information.
Where is the NCT05526950 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT05526950 clinical trial?
NCT05526950 is sponsored by Lund University Hospital. The principal investigator is Sandra Lindstedt, MD, PhD at Skånes universitetssjukhus Lund. The trial plans to enroll 116 participants.