Lung PGD Biomarkers in Organ Donors

NCT03089489 | Unknown

• 1 other identifier: B039201731131
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

PGD is a syndrome characterized by alveolocapillary barrier structural and functional alterations with surfactant inactivation and vascular permeability increase, which cause lung edema, parenchymal infiltrate and progressive hypoxemia. PGD may be enhanced in lung donor. Inflammatory and structural changes may be present in the lungs before organ recovery and/or after organ preservation. The investigators aim to identify the surfactant protein, inflammatory and structural changes in lung donor before and after cold ischemia, and biomarkers to PGD in lung recipients.

Conditions

Lung Transplant Failure

Keywords

Primary graft dysfunction; Lung transplantation; Surfactant Protein; inflammation

Outcome Measures

Primary Outcomes (1)

• Lung Biomarkers for primary graft dysfunction in organ donors

  The investigators aim te describe lung donor structural and molecular changes in relation of PGD occurrence in recipient.

  5-7 years

Study Arms (2)

Lung recipients with PGD

in the first 72 hours following lung transplantation, the lung recipients have blood gases and chest X-Ray to assess the occurrence of primary graft dysfunction. Chest X-Ray infiltrate and pathological PaO2/FiO2 ratio describe PGD occurence

Diagnostic Test: lung biomarkers in organ donor for PGD in lung recipient

Lung recipients PGD Free

In the first 72 hoours following lung transplantation, if the Cest X-ray is normal, the patient is considered PGD-free

Diagnostic Test: lung biomarkers in organ donor for PGD in lung recipient

Interventions

lung biomarkers in organ donor for PGD in lung recipient DIAGNOSTIC_TEST

Lung biopsies in organ donor before and after cold ischemia

Lung recipients PGD Free; Lung recipients with PGD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All lung donors and their lung recipients who reached the criteria for lung recovery and transplantation

You may qualify if:

• All organ donors and their lung recipients who reached the criteria for lung recovery and transplantation

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Biospecimen

Retention: SAMPLES WITH DNA

Lung and blood samples in organ donors

MeSH Terms

Conditions

Primary Graft Dysfunction; Inflammation

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Asmae Belhaj, MD, PhD

  CHU UCL Namur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmae Behaj, MD, PhD

CONTACT

003281423153; asmae.belhaj@uclouvain.be

Benoit Rondelet, MD, PhD

CONTACT

003281423149; benoit.rondelet@uclouvain.be

Study Design

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

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 24, 2017
• Study Start: April 1, 2017
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2024
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share