NCT01746914

Brief Summary

72 hours after lung transplantation, patients undergo a positron emission tomography (PET) scan and a computed tomography (CT) scan in order to analyse lung function and morphology. Aim of the study is to analyse complications onset (in particular primary graft dysfunction), and evaluate 90 days mortality after lung transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

December 7, 2012

Last Update Submit

March 29, 2016

Conditions

Disorder Related to Lung Transplantation

Outcome Measures

Primary Outcomes (1)

  • Number of patients alive

    up to 90 days from transplantation

Secondary Outcomes (2)

  • incidence of complications other than primary graft dysfunction

    72 hours and 90 days

  • incidence of primary graft dysfunction

    72 hours and 90 days after transplantation

Study Arms (1)

Lung transplantated patients

Patients undergone lung transplantation

Eligibility Criteria

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

Lung Transplantated patients

You may qualify if:

  • lung transplantation
  • ≥ 18 years

You may not qualify if:

  • \< 18 years
  • patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milan, 20122, Italy

Location

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

  • Franco Valenza, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

January 1, 2016

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

IT(1)