The University of Alberta Negative Pressure Ventilation Ex-Vivo Lung Perfusion (NPV-EVLP) Trial

Not Applicable

Completed

• Conditions: Ex-Vivo Lung Transplantation
• Interventions: Device: NPV-EVLP

• Registration Number: NCT03293043
• Lead Sponsor: University of Alberta

Brief Summary

This project is focused on helping one of the most vulnerable patient populations in medicine, patients with end-stage chronic lung disease. Lung transplantation is the only cure for end-stage lung disease, however, due to the persistent shortage of donor organs, either due to low organ donation rates or unacceptable organs, only a minority of patients receive desperately needed lung transplants. Currently less than 30% of potential donated thoracic organs are being used for transplantation. The major causes for under utilization of donor thoracic organs are injury sustained by the lungs in trauma or emergency resuscitation or lungs that come from donors who are pronounced dead due to cardiac arrest (known as DCD donors). It has been hypothesized that these injuries may be reversible or repairable if there was an opportunity to evaluate and repair these organs outside of the body (ex-vivo), prior to transplantation. In fact, studies have shown that the use of normothermic Ex-Vivo Lung Perfusion (EVLP) has increased the rate of donor organ utilization at centers that have adopted the technology.

Current methodology for all clinically available EVLP devices uses Positive Pressure Ventilation (PPV). Researchers at the University of Alberta (UofA), however, have developed an EVLP device that will apply Negative Pressure Ventilation (NPV) to the lungs, as opposed to PPV, which is the most ideal mimicry of native lung physiology. The objective of this early feasibility safety trial is to show that the UofA developed NPV-EVLP device is acceptable in evaluating and improving the quality of marginal donor lungs compared to currently used EVLP devices, ultimately allowing for these types of donor lungs to be safely transplanted into patients on the lung transplant recipient waitlist.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-26
• Study Start: 2018-10-11
• Status Verified: 2021-04
• Primary Completion: 2021-04-22
• Study Completion: 2021-04-22
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	NPV-EVLP	After initial screening, appropriately obtained informed consent and confirmation of eligibility at time of transplant, those recipients (a total of 12 subjects) who agree to continue as participants will receive reconditioned marginal lungs should the lungs on the device meet acceptable criteria to proceed with clinical transplantation.

Primary Outcome Measures

Name	Time	Method
Patient survival post transplantation at Day30	Day30 post-Transplant	The primary end point is a co-primary endpoint comparing patient survival rates post transplantation at Day30 (Outcome 1) and rates of Primary Graft Dysfunction (PGD) Grade 3 in the first 72 hours (Outcome 2) with success measured only if both endpoints are met.
Primary Graft Dysfunction (PGD) Grade 3 in the first 72Hours	First 72Hours post-Transplant	The primary end point is a co-primary endpoint comparing patient survival rates post transplantation at Day30 (Outcome 1) and rates of Primary Graft Dysfunction (PGD) Grade 3 in the first 72 hours (Outcome 2) with success measured only if both endpoints are met.

Secondary Outcome Measures

Name	Time	Method
ICU LOS	From admission to the ICU through to exact date of ICU Discharge (up to 30Days)	ICU length of stay (LOS) post-Transplant will be captured.
Hospital LOS	From date of Transplant through to exact date of Index Hospital Discharge (up to 6Months)	Index hospital length of stay (LOS) length of stay post-Transplant will be captured until D/C.
Primary Graft Dysfunction (PGD) Grades	Time0 (ICU Admission), Time24Hours (post-Transplant), Time48Hours (post-Transplant), and Time72Hours (post-Transplant)	PGD scores will be assessed a Grade of 0, 1, 2 or 3 (per ISHLT Guidelines) at Time0 (ICU Admission), Time24Hours (post-Transplant), Time48Hours (post-Transplant), and Time72Hours (post-Transplant) with respect to PaO2/FiO2 ratios and presence/absence of radiographic infiltrates consistent with pulmonary edema.
Duration of Mechanical Ventilation post-Transplant	Time0 (ICU Admission post-Transplant) through to exact time of extubation post-Transplant	The duration of Mechanical Ventilation post-Transplant will be captured until extubation.
FEV1	6Months and 1Year	FEV1 results from spirometry efforts at 6Months and 1Year will be captured.
Quality of Life (SF-36)	6Months and 1Year	Quality of Life measured by the 36-Item Short Form Survey (SF-36) at 6Months and 1Year will be captured.

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada