NCT04194398

Brief Summary

Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

December 9, 2019

Last Update Submit

April 6, 2022

Conditions

OCS Lung System

Outcome Measures

Primary Outcomes (8)

  • Patient and graft survival

    Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.

    2 years

  • Patient and graft survival

    Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.

    3 years

  • Patient and graft survival

    Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.

    4 years

  • Patient and graft survival

    Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.

    5 years

  • Presence or absence of bronchiolitis obliterans sydrome (BOS)

    Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.

    2 years

  • Presence or absence of bronchiolitis obliterans sydrome (BOS)

    Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.

    3 years

  • Presence or absence of bronchiolitis obliterans sydrome (BOS)

    Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.

    4 years

  • Presence or absence of bronchiolitis obliterans sydrome (BOS)

    Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.

    5 years

Study Arms (1)

OCS Expand Trial Cohort

All patients previously enrolled in the EXPAND Lung trial.

Device: OCS Lung System

Interventions

OCS Lung SystemDEVICE

Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.

OCS Expand Trial Cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.

You may qualify if:

  • Registered male or female primary double lung transplant candidate
  • Age ≥18 years old
  • Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

You may not qualify if:

  • Prior solid organ or bone marrow transplant
  • Single lung recipient
  • Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Hospitals Leuven

Leuven, 3000, Belgium

Location

Hannover Medical School

Hanover, D-300625, Germany

Location

Related Publications (1)

  • Loor G, Warnecke G, Villavicencio MA, Smith MA, Zhou X, Kukreja J, Ardehali A, Hartwig MG, Daneshmand MA, Hertz MI, Huddleston SJ, Haverich A, Madsen JC, Neyrinck A, Van Raemdonck D. Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantation. EClinicalMedicine. 2025 Jul 8;85:103334. doi: 10.1016/j.eclinm.2025.103334. eCollection 2025 Jul.

    PMID: 40686680DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

December 31, 2018

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

April 7, 2022

Record last verified: 2022-02

Locations

BE(1)US(6)DE(1)