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Planned Semi-Elective Lung Tx Study

NCT ID: NCT04616365

Last Updated: 2023-12-28

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2023-04-21

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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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

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcelo Cypel, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

University Health Network (Toronto General Hospital)

Toronto, Ontario, Canada

Site Status

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, , Spain

Site Status

Countries

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Austria Canada Spain

References

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Iskender I. Technical Advances Targeting Multiday Preservation of Isolated Ex Vivo Lung Perfusion. Transplantation. 2024 Jun 1;108(6):1319-1332. doi: 10.1097/TP.0000000000004992. Epub 2024 May 23.

Reference Type DERIVED
PMID: 38499501 (View on PubMed)

Ali A, Hoetzenecker K, Luis Campo-Canaveral de la Cruz J, Schwarz S, Barturen MG, Tomlinson G, Yeung J, Donahoe L, Yasufuku K, Pierre A, de Perrot M, Waddell TK, Keshavjee S, Cypel M. Extension of Cold Static Donor Lung Preservation at 10 degrees C. NEJM Evid. 2023 Jun;2(6):EVIDoa2300008. doi: 10.1056/EVIDoa2300008. Epub 2023 Apr 20.

Reference Type DERIVED
PMID: 38320127 (View on PubMed)

Other Identifiers

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19-6364

Identifier Type: -

Identifier Source: org_study_id