N/A
Completed N=320
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
Lung Preservation
Source: ClinicalTrials.gov NCT01630434 ↗
Enrolled (actual)
320
Serious AEs
59.6%
Results posted
Jul 2022
Primary outcomePrimary: 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
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).
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 | — |
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. Informational only — not medical advice.