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Early Endoscopic Indicators for OACs After Lung Transplantation: Development of a Novel Mucosal Healing Score (OAC)

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ClinicalTrials.gov Identifier: NCT00940147
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Airway complications are a significant cause of morbidity after lung transplantation (LTx). Bronchoscopic evaluation may help to identify risk factors for requiring interventions later.

Condition or disease
Airway Complication Which Require Any Intervention

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 Design

Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Indicators for Obstructive Airway Complications After Lung
Study Start Date : January 2007
Primary Completion Date : June 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
patients with OAC, Score finding
2
patients without OAC, Score finding


Outcome Measures

Primary Outcome Measures :
  1. Primary endpoint of this study was any obstructive airway complication (AC) which required desobliterative intervention. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. secondary endpoint included anastomosis-related death. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
LTx 01.2007-05.2009
Criteria

Inclusion Criteria:

  • 3 month survivor after LTx
  • no OAC

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940147


Locations
Germany
Hannover Medical School
Hannover, Germany, 30625
Sponsors and Collaborators
Thomas Fuehner
More Information

Additional Information:
Responsible Party: Thomas Fuehner, Principal Investigator, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00940147     History of Changes
Other Study ID Numbers: 2008_01
OAC_1.0
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013