Planned Semi-Elective Lung Tx Study

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2023-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In the current practice of lung transplantation, transplants are performed on a 24/7 schedule with a significant amount of procedures occurring overnight in order to minimize organ ischemic time. However, transplantation during the day time may lead to several advantages related to patient safety, including the presence of rested staff performing optimally, larger number of in-house professionals for emergency situations, and professional well-being. Advances and refinements in preservation practices have evolved to show that extended periods of preservation can be achieved without compromising outcome. Based on this, it is hypothesized that the avoidance of nighttime lung transplantation through prolonged pulmonary preservation will lead to at least similar patient outcomes compared to the current practice of 24/7 transplantation. During the period of this study, overnight transplants will be moved to a later start time (earliest 6AM). If lungs meet criteria for direct transplantation, they will be preserved with cold static preservation at 10°C within a special refrigerator. The maximum preservation time from donor cold flush to recipient anesthesia start time will be 12 hours.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Planned Semi-Elective Lung Tx Study

NCT04601818

To Compare Lung Transplant Outcomes Between Study Patients and Standard Patients Who Have Already Undergone Lung Transplantation by Conventional Procedures Lung Transplant

RECRUITING NA

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

NCT04568694

Pulmonary Disease

COMPLETED NA

Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation

NCT00536926

Lung Transplantation

COMPLETED PHASE3

Is it Possible to Use the Timed Performance Tests in Lung Transplantation Candidates to Determine the Exercise Capacity?

NCT03531138

Pulmonary Rehabilitation Exercise Capacity Exercise Test

COMPLETED NA

Randomized Comparison of Awake Nonresectional Versus Nonawake Resectional Lung Volume Reduction Surgery

NCT00566839

Pulmonary Emphysema

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Semi-Elective Lung Transplantation

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

Group Type EXPERIMENTAL

Semi-Elective Lung Transplantation

Intervention Type PROCEDURE

When suitable donor lungs become available for a consented recipient, the transplant procedure (anesthesia starting time) will be allowed to begin earliest at 6am with the lungs being preserved at 10°C cold static preservation upon organ arrival to our hospital using a specific incubator, regardless of when donor cross clamp occurs. The maximum time allowed between donor cross clamp and recipient anesthesia initiation will be 12h.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Semi-Elective Lung Transplantation

When suitable donor lungs become available for a consented recipient, the transplant procedure (anesthesia starting time) will be allowed to begin earliest at 6am with the lungs being preserved at 10°C cold static preservation upon organ arrival to our hospital using a specific incubator, regardless of when donor cross clamp occurs. The maximum time allowed between donor cross clamp and recipient anesthesia initiation will be 12h.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary lung transplantation
* Informed consent provided
* 18-80 years old

* Age ≤70 years old
* Donor lungs are suitable to go straight to lung transplantation

Exclusion Criteria

* Re-transplantation
* Multi-organ transplantation
* \>80 years old

* Age \>70 years old
* Concerns with organ preservation technique
* Donor lungs require assessment by Ex Vivo Lung Perfusion (EVLP)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No