NCT02032069

Brief Summary

Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. We will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

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

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

January 6, 2014

Last Update Submit

March 13, 2016

Conditions

Primary Graft Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Number of Recipient with primary graft dysfunction

    one year

Study Arms (2)

NHBD

Non Heart Beating Donors

Other: no intervention

BDD

Brain death donors

Other: no intervention

Interventions

no interventionOTHER
BDDNHBD

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Organ donors and lung recipients

You may qualify if:

  • All the organ donors for lung grafts.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

lung tissues and serum

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion InjuryVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 9, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

BE(1)