NCT Number: NCT02906436
Ex-Vivo Lung Reconditioning
Only about 15% of the potential candidates for lung donation are considered suitable for transplantation. Thus, a strategy that could improve the quality and precision of assessment of nonacceptable donor lungs could have a major impact on reducing waiting time and mortality while on the list.
A new method for ex vivo lung perfusion (EVLP) has been developed recently by Steen and colleagues to assess the quality of lungs from a non-heart-beating donor. The method can also be used to recondition "marginal" and nonacceptable donor lungs.
After harvesting, the lungs were perfused ex vivo with Steen Solution, an extracellular matrix with high colloid osmotic pressure. A membrane oxygenator connected to the circuit received gas from a mixture of nitrogen and carbon dioxide, maintaining a normal mixed venous blood gas level in the perfusate. The lungs were gradually rewarmed, reperfused, and ventilated for evaluation through analyses of oxygenation capacity, pulmonary vascular resistance (PVR), lung compliance (LC), and biopsy.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Centre chirugical Marie Lannelongue, Le Plessis-Robinson, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients on the waiting list for lung transplantation and for which the Biomedicine -Agency has awarded a lung transplantation after Ex-Vivo lung reconditioning
- Patients affiliated to a social security system;
- Patients who consented to participate in writing
Exclusion criteria
-Patients under tutorship or unable to consent or institutionalized
Treatment and study plan
Primary outcomes
-
number of "transplantable" grafts and Reduced waiting time before transplantation
Time frame: 12 months
Secondary outcomes
-
Difference of data obtained 2 hours after Ex-Vivo lung reconditioning with those obtained 4 hours after Ex-Vivo lung reconditioning
Time frame: 4 hours after Ex-Vivo lung reconditioning
-
Number of deaths of patients on waiting list
Time frame: 5 years
-
survival time after lung transplantation with ExVivo lung reconditioning
Time frame: 1 year after end of study
-
Quality of life scale score after lung transplantation with ExVivo lung reconditioning
Time frame: 1 year after end of study
Sponsors and collaborators
Lead sponsor
Hopital Foch
Other
Registry information
Official study title
Pilot Study of Lung Transplantation After Ex-Vivo Lung Reconditioning
Acronym: ExVivo
Important dates
- Study start
- 2011
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Sep 20, 2016
- Registry last updated
- Apr 20, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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