Early Endoscopic Indicators for OACs After Lung Transplantation: Development of a Novel Mucosal Healing Score (OAC)
June 5, 2013 updated by: Thomas Fuehner
Early Indicators for Obstructive Airway Complications After Lung
Airway complications are a significant cause of morbidity after lung transplantation (LTx).
Bronchoscopic evaluation may help to identify risk factors for requiring interventions later.
Study Overview
Status
Completed
Detailed Description
The investigators evaluated lung transplant recipients prospectively.
Adult patients surviving 90 day after LTx will be included.
The investigators propose a classification of airway healing based on the endoscopic bronchial appearances at days 7, 14, 21, 90, 180 and 365 after LTx.
A score system including mucosal healing, full tissue necrosis (=dehiscence), lose sutures, fibrin plugs, polyps and malacia will be developed (max.
score 8 points/date).
Endoscopic findings will be correlated with the development of obstructive airway complications (OAC, requiring >1 intervention).
Afterwards the new score system will be applied prospectively in the patients.
Study Type
Observational
Enrollment (Actual)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hannover, Germany, 30625
- Hannover Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
LTx 01.2007-05.2009
Description
Inclusion Criteria:
- 3 month survivor after LTx
- no OAC
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1
patients with OAC, Score finding
|
|
2
patients without OAC, Score finding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Primary endpoint of this study was any obstructive airway complication (AC) which required desobliterative intervention.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
secondary endpoint included anastomosis-related death.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
July 14, 2009
First Submitted That Met QC Criteria
July 14, 2009
First Posted (Estimate)
July 15, 2009
Study Record Updates
Last Update Posted (Estimate)
June 6, 2013
Last Update Submitted That Met QC Criteria
June 5, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 2008_01
- OAC_1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.