NCT01963780

Brief Summary

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.

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 not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
4 countries

11 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

First Submitted

Initial submission to the registry

September 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

July 7, 2022

Completed
Last Updated

July 7, 2022

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

September 4, 2013

Results QC Date

April 6, 2022

Last Update Submit

June 10, 2022

Conditions

Lung Transplant

Keywords

lung transplantationlung preservationbreathing lung transplant

Outcome Measures

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

    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.

    30 days post lung transplantation

Secondary Outcomes (2)

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

    72 hours post lung transplantation

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

    72 hours post lung transplantation

Other Outcomes (2)

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

    30 days post lung transplantation

  • Long-term Survival: Survival at 12-months Post-transplant

    12-months

Study Arms (1)

OCS Lung Tx.

EXPERIMENTAL

A prospective, pivotal single arm trial.

Device: OCS Lung Preservation

Interventions

OCS Lung PreservationDEVICE
OCS Lung Tx.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

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, San Francisco

San Francisco, California, 94143, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Leuven Hospital

Leuven, 3000, Belgium

Location

Hannover Medical School

Hanover, D-300625, Germany

Location

Hospital Universitario Puerta De Hierro

Madrid, 25222, Spain

Location

Related Publications (1)

  • Loor G, Warnecke G, Villavicencio MA, Smith MA, Kukreja J, Ardehali A, Hartwig M, Daneshmand MA, Hertz MI, Huddleston S, Haverich A, Madsen JC, Van Raemdonck D. Portable normothermic ex-vivo lung perfusion, ventilation, and functional assessment with the Organ Care System on donor lung use for transplantation from extended-criteria donors (EXPAND): a single-arm, pivotal trial. Lancet Respir Med. 2019 Nov;7(11):975-984. doi: 10.1016/S2213-2600(19)30200-0. Epub 2019 Aug 1.

    PMID: 31378427DERIVED

Results Point of Contact

Title
VP, Clinical Affairs
Organization
TransMedics, Inc.
ldamme@transmedics.com
978.552.0900

Study Officials

  • Abbas Ardehali, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Dirk Van Raemdonck, MD, PhD

    University of Leuven Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

October 16, 2013

Study Start

November 1, 2013

Primary Completion

November 22, 2016

Study Completion

April 1, 2018

Last Updated

July 7, 2022

Results First Posted

July 7, 2022

Record last verified: 2018-04

Locations

BE(1)DE(1)US(8)ES(1)