Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-12-03

Brief Summary

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This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.

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Detailed Description

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Conditions

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Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Delayed Lung Transplantation

Patients that received lung(s) delayed for transplantation

Group Type EXPERIMENTAL

Delayed Lung Transplantation

Intervention Type PROCEDURE

Transplants with a planned recipient anesthesia start time between 10:00 pm and 6:00 am will be allowed to move to a start time between 6:00 am and 8:00 am at the earliest. Donor lung(s) cross clamp time must occur between 5:00 pm and 4:00 am. Lungs that meet criteria will be transported in the usual fashion in a cooler of ice at 4oC. Upon arrival to NYULH, the lungs will be transferred to cold static preservation at 10oC within a specific incubator located in a NYULH OR (MYTEMP™65HC, Benchmark Scientific).

Conventional Lung Transplantation

Reference Therapy

Group Type ACTIVE_COMPARATOR

Conventional Lung Transplantation

Intervention Type PROCEDURE

Reference Therapy

Interventions

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Delayed Lung Transplantation

Transplants with a planned recipient anesthesia start time between 10:00 pm and 6:00 am will be allowed to move to a start time between 6:00 am and 8:00 am at the earliest. Donor lung(s) cross clamp time must occur between 5:00 pm and 4:00 am. Lungs that meet criteria will be transported in the usual fashion in a cooler of ice at 4oC. Upon arrival to NYULH, the lungs will be transferred to cold static preservation at 10oC within a specific incubator located in a NYULH OR (MYTEMP™65HC, Benchmark Scientific).

Intervention Type PROCEDURE

Conventional Lung Transplantation

Reference Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Recipient is ≥ 18 years old
* Recipient, or their Legally Authorized Representative is able and willing to sign informed consent
* Recipient meets standard listing criteria for lung transplantation

Exclusion Criteria

* Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP)
* Recipient is \< 18 years old
* Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation
* Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No