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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary endpoints: 3 to 4
    • Start date changed from estimate of Aug 14, 2023 to Sep 7, 2023
    • Secondary endpoints: details revised at 6 of 14 entries
    • Site details revised
  2. Primary completion date: Dec 31, 2026 to Dec 31, 2027v3 Show 6 more changesShow less
    • Start date: Jan 1, 2023 to Aug 14, 2023
    • Primary endpoints revised (3)
    • Enrollment target: 120 to 116
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints: 11 to 14
    • Publications: 4 to 5
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05526950
Lead Sponsor Lund University Hospital
Conditions
(from sponsor)		 Lung Transplant Failure, Lung Transplant; Complications
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov