By InvitationNot Applicable

Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

United States2,000 participantsStarted 2021-10-15

Plain-language summary

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Donor and donor lungs matched to the prospective recipient based upon institutional medical practice * Registered male or female primary lung transplant candidates including pediatric candidates Exclusion Criteria: * Donor and donor lungs that do not meet institutional clinical requirements for transplantation * Patients who are incarcerated persons (prisoners) * Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas) * Patients who are receiving multiple organ transplants

What they're measuring

Number of subjects with Primary Graft Dysfunction (PGD)

Timeframe: Post-transplant through 1 year post

Number of subjects with rejection

Timeframe: Post-transplant through 1 year post

Survival

Timeframe: Post-transplant through 1 year post

ICU Length of Stay

Timeframe: Transplant through 1 year post-transplant

Hospital Length of Stay

Timeframe: Transplant through 1 year post-transplant

Trial details

NCT IDNCT04930289

SponsorParagonix Technologies

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-06-15

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