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Procedure

EVLP for Lung Transplant (EVLP-CHUM Trial)

N/A
Recruiting
Led By Pasquale Ferraro, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients requiring invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO) support
Patients aged less than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after transplantation
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to clean and prep donor lungs so that they can be safely transplanted. The trial will also study the lungs' inflammatory response before transplant.

Who is the study for?
This trial is for adults over 18 who are on the active waiting list for their first lung transplant and have given informed consent. They must re-confirm consent on the day of transplant and have received patient information sheets beforehand. It's not open to those under 18, without informed consent, or needing mechanical ventilation or ECMO support.
What is being tested?
The study tests a new technique called Ex Vivo Lung Perfusion (EVLP) which aims to make previously unusable donor lungs safe for transplantation. The process also allows researchers to study inflammatory responses in the lungs before they're transplanted.
What are the potential side effects?
While specific side effects aren't listed, EVLP may carry risks similar to other lung transplant procedures such as infection, rejection of the donor lung, inflammation due to biomarker evaluation processes, and complications from surgery.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need a machine to help me breathe.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after transplantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measure of survival
Secondary study objectives
90 day Mortality
Duration of hospital stay
Duration of mechanical ventilation
+2 more
Other study objectives
Biomarkers

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EVLP GroupExperimental Treatment1 Intervention
Recipients receive reconditioned EVLP donor lungs and current standard of care for lung transplant is administered.
Group II: Standard GroupActive Control1 Intervention
Recipients receive standard donor lungs as per current clinical practice. No experimental procedures will be carried out.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EVLP Group
2011
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,470 Total Patients Enrolled
Fondation Pour La Recherche en Chirurgie Thoracique De MontrealUNKNOWN
Centre de Recherche du Centre Hospitalier de l'Université de MontréalOTHER
53 Previous Clinical Trials
123,510 Total Patients Enrolled

Media Library

EVLP (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02235610 — N/A
Lung Transplant Research Study Groups: Standard Group, EVLP Group
Lung Transplant Clinical Trial 2023: EVLP Highlights & Side Effects. Trial Name: NCT02235610 — N/A
EVLP (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02235610 — N/A
~0 spots leftby Dec 2024
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