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Completed

NCT Number: NCT01963780

International EXPAND Lung Pivotal Trial

To evaluate the safety and effectiveness of the OCS™ Lung to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

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Key information

Conditions

Lung Transplant

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leuven Hospital, Leuven, Belgium

Loading trial locations.

About this study

The OCS™ Lung is to be used to recruit, preserve and assess donor lungs that may not meet current standard donor lung acceptance criteria from one or more of the following characteristics:

  • Donor PaO2/FiO2 ≤ 300 mmHg; or
  • Expected ischemic time > 6 hours; or
  • Donor after Cardiac Death (DCD donor); or
  • Donor age ≥55 years old

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one of the following:
  • Donor PaO2/FiO2 ≤ 300 mmHg; or
  • Expected ischemic time > 6 hours; or
  • Donor after Cardiac Death (DCD donor); or
  • Donor age ≥55 years old

Exclusion criteria

  • • Presence of moderate to severe traumatic lung injury with air and/or blood leak
  • Presence of confirmed active pneumonia or persistent purulent secretions on repeated bronchoscopy evaluation or ET suction
  • Previous history of pulmonary disease
  • Multiple transfusions of >10 pRBCs units
  • ABO incompatibility
  • Tobacco history of >20 pack years

Treatment and study plan

OCS Lung Preservation

Device

Primary outcomes

  1. Number of Participants With Composite Endpoint of Patient Survival at Day-30 Post Transplant and Absence of Primary Graft Dysfunction (PGD) Grade 3 During the First 72 Hours Post Lung Transplant

    Time frame: 30 days post lung transplantation

    Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.

Secondary outcomes

  1. Number of Participants With ISHLT Primary Graft Dysfunction (PGD) Grade 2 or 3 at T72 Hours Post Lung Transplantation

    Time frame: 72 hours post lung transplantation

    Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.

  2. Number of Participants With Primary Graft Dysfunction Grade 3 at T72 Hours

    Time frame: 72 hours post lung transplantation

    Primary graft dysfunction is graded on a scale of 0 to 3 according to the 2005 ISHLT PGD grading consensus. Grade 0 is considered the least severe and grade 3 is considered a more severe outcome.

Other outcomes

  1. Primary Safety Endpoint: Number of Lung Graft Related Serious Adverse Events During the First 30 Days Post Lung Transplantation

    Time frame: 30 days post lung transplantation

    An LGRSAE event is defined as the occurrence of any of the following four categories of adverse events that are also serious; acute rejection, respiratory failure, bronchial anastomotic complication, and major pulmonary-related infection.

  2. Long-term Survival: Survival at 12-months Post-transplant

    Time frame: 12-months

    Survival outcomes were collected through one year post-transplant.

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Lung For Recruiting, Preserving and Assessing Expanded Criteria Donor Lungs for Transplantation (EXPAND Trial)

Acronym: EXPANDLung

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Oct 16, 2013
Registry last updated
Jul 7, 2022

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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