N/A
N=320
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
Lung Preservation
Bottom Line
View on ClinicalTrials.gov: NCT01630434 ↗Enrolled (actual)
320
Serious AEs
59.6%
Results posted
Jul 2022
Primary outcome: Primary: A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation. — 112; 116; 112; 119 Participants — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OCS Lung (Device); Cold flush and storage (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TransMedics
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Composite of Patient Survival at Day 30 Post Transplantation, and Absence of International Society for Heart & Lung Transplantation (ISHLT) Primary Graft Dysfunction (PGD3) Grade 3 Within the First 72 Hours Post-transplantation. |
112; 116; 112; 119 | 0.004 sig |
| SECONDARY Participants With International Society for Heart & Lung Transplantation (ISHLT) PGD Grade 3 at 72 Hours Post-transplantation |
3; 6; 7; 7 | 0.0003 sig |
| SECONDARY Participants With ISHLT PGD Grade 2 or 3 at 72 Hours Post-transplantation |
16; 13; 22; 14 | 0.118 |
| SECONDARY Patient Survival at Day 30 |
135; 165; 142; 168 | — |
Summary
A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
Eligibility Criteria
Inclusion Criteria
- Registered primary double-lung transplant candidate
- Age > or equal to 18
- Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion Criteria
- Prior solid organ or bone marrow transplant
- Single lung recipient
- Multiple organ transplant recipient
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
Data sourced from ClinicalTrials.gov (NCT01630434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.