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Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
NA trial testing Toronto EVLP System™ in Lung Disease in 118 participants. Completed in 7 November 2019.
| Lead sponsor | Lung Bioengineering Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 118 |
| Start date | 18 July 2015 |
| Primary completion | 21 November 2018 |
| Estimated completion | 7 November 2019 |
| Sites | 8 locations across United States |
Lung Bioengineering Inc.
18 and older, any sex, with Lung Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Primary Graft Dysfunction is a scale published by the International Society of Heart and Lung Transplantation that uses patient oxygenation and radiographic results to score patients on a 0 (zero) to 3 (three) scale, with 3 being the most significant dysfunction.
| Group | Value | 95% CI |
|---|---|---|
| EVLP Double Lung Group | 8 | |
| EVLP Single Lung Group | 8 | |
| Control Group | 2 |
The number of participants that survived to 30 days post-transplant.
| Group | Value | 95% CI |
|---|---|---|
| EVLP Double Lung Group | 35 | |
| EVLP Single Lung Group | 31 | |
| Control Group | 52 |
Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | EVLP Double Lung Group | EVLP Single Lung Group | Control Group |
|---|---|---|---|---|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Lung Transplant Rejection | Immune system disorders | — | — | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Transplant Rejection | Immune system disorders | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Cytomegalovirus Viremia | Infections and infestations | — | — | — |
| Cardiac Arrest | Cardiac disorders | — | — | — |
| Delerium | Nervous system disorders | — | — | — |
| Septic shock | Infections and infestations | — | — | — |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — | — |
| Pneumatosis intestinalis | Gastrointestinal disorders | — | — | — |
| Complications of transplanted lung | Injury, poisoning and procedural complications | — | — | — |
| Shock hemorrhagic | Vascular disorders | — | — | — |
| Pneumonia pseudomonal | Infections and infestations | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Postoperative wound infection | Infections and infestations | — | — | — |
| Respiratory syncytial virus infection | Infections and infestations | — | — | — |
| Bronchial anastomosis complication | Injury, poisoning and procedural complications | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — |
| Reaction | System | EVLP Double Lung Group | EVLP Single Lung Group | Control Group |
|---|---|---|---|---|
| Transplant rejection | Immune system disorders | — | — | — |
| Lung transplant rejection | Immune system disorders | — | — | — |
| Lower respiratory tract infection bacterial | Infections and infestations | — | — | — |
| Lung infection pseudomonal | Infections and infestations | — | — | — |
| Bronchopulmonary aspergillosis | Infections and infestations | — | — | — |
| Rhinovirus infection | Infections and infestations | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — |
| Respiratory tract infection bacterial | Infections and infestations | — | — | — |
| Transmission of an infectious agent via transplant | Infections and infestations | — | — | — |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — |
| Bronchitis | Infections and infestations | — | — | — |
| Cytomegalovirus viremia | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Delirium | Psychiatric disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — |
| Drug hypersensitivity | Immune system disorders | — | — | — |
| Bronchitis bacterial | Infections and infestations | — | — | — |
| Diverticulitis | Infections and infestations | — | — | — |
| Haemophilus infection | Infections and infestations | — | — | — |
| Infectious pleural effusion | Infections and infestations | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Bronchial anastomosis complication | Injury, poisoning and procedural complications | — | — | — |
| Toxicity to various agents | Injury, poisoning and procedural complications | — | — | — |
| Metabolic acidosis | Metabolism and nutrition disorders | — | — | — |
| Mental status changes | Psychiatric disorders | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Decubitis ulcer | Skin and subcutaneous tissue disorders | — | — | — |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | — | — | — |
| Deep vein thrombosis | Vascular disorders | — | — | — |
Most-reported serious reactions: Acute Respiratory Failure, Hypoxia, Lung Transplant Rejection, Respiratory Failure, Pneumonia, Bronchostenosis, Transplant Rejection, Dyspnea.
Data from ClinicalTrials.gov NCT02234128 adverse events section.
This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02234128.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing